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JWY

441 FDA 510(k) clearances · Product code

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RecordFirmDate
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX (K941459)Baxter Diagnostics, Inc.1995-02-03
DRIED GRAM NEGATIVE/CEFMETAZOLE (K941317)Baxter Diagnostics, Inc.1995-01-31
BBL CRYSTAL MRSA ID SYSTEM (K941997)Becton Dickinson Microbiology Systems1995-01-27
PASCO MIC AND MIC/ID PANELS (K946126)Pasco Laboratories, Inc.1995-01-17
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE (K942267)Baxter Diagnostics, Inc.1995-01-09
MICRODILUTION/LORACARBEF PANELS (K942089)Baxter Diagnostics, Inc.1995-01-09
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K943510)Baxter Diagnostics, Inc.1994-12-02
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K944651)Baxter Diagnostics, Inc.1994-11-18
ETEST FOR AMPICILLIN/SULBACTAM 2/1 (K935519)Ab Biodisk North America, Inc.1994-11-04
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION (K944723)Alamar Biosciences, Inc.1994-10-21
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL (K934323)Baxter Diagnostics, Inc.1994-10-19
PASCO MIC AND MIC/ID PANELS (K944517)Pasco Laboratories, Inc.1994-10-19
PASCO MIC PANELS/ GENT & STREP SYNERGY (K934380)Pasco Laboratories, Inc.1994-01-27
PASCO MIC AND MIC/ID PANELS (K933709)Pasco Laboratories, Inc.1993-12-27
PASCO MIC AND MIC/ID PANELS (K933746)Pasco Laboratories, Inc.1993-12-27
ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K933885)Alamar Biosciences, Inc.1993-11-16
PASCO MIC AND MIC/ID PANELS (K933849)Pasco Laboratories, Inc.1993-11-16
PASCO MIC AND MIC/ID PANELS (K932917)Pasco Laboratories, Inc.1993-08-18
DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K932082)Baxter Diagnostics, Inc.1993-07-20
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K930469)Alamar Biosciences Laboratory, Inc.1993-06-25
BBL CRYSTAL MRSA ID SYSTEM (K926294)Becton Dickinson Microbiology Systems1993-05-18
PASCO MIC AND MIC/ID PANELS (K931069)Pasco Laboratories, Inc.1993-05-12
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K930055)Alamar Biosciences Laboratory, Inc.1993-04-05
DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K926545)Baxter Diagnostics, Inc.1993-03-26
SENSITITRE SUSCEPTIBILITY PLATES (K923045)Radiometer America, Inc.1993-03-09
CATION ADJUSTED MUELLER HINTON BROTH (K925644)Pasco Laboratories, Inc.1993-01-15
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS (K922458)Baxter Healthcare Corp1992-12-11
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (K923684)Analytical Products, Inc.1992-12-03
ANTIMICROBIAL SUSCEPTIBILITY TEST (K924500)Alamar Biosciences Laboratory, Inc.1992-11-30
API UNISCEPT KB/TYPE 2 AND 3 (K922926)Analytical Products, Inc.1992-10-13
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K922780)Alamar Biosciences Laboratory, Inc.1992-08-20
ANTIMICROBIAL SUSCETIBILITY TEST PANEL (K922003)Alamar Biosciences Laboratory, Inc.1992-08-19
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K922168)Alamar Biosciences Laboratory, Inc.1992-07-28
HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE (K912778)Sensititre Microbiology A Div. of Radiometer1992-02-18
THE E TEST, MODIFICATION (K913459)Ab Biodisk1991-09-25
API UNISCEPT KB (K912965)Analytab Products, Inc.1991-09-06
API UNISCEPT MIC/UNISCEPT MICRO-MIC (K912964)Analytab Products, Inc.1991-08-29
JUSTONE(TM) (K912846)Sensititre Microbiology A Div. of Radiometer1991-08-22
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) (K912613)Sensititre Microbiology A Div. of Radiometer1991-08-22
ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN (K911558)Alamar Biosciences Laboratory, Inc.1991-05-15
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN (K911392)Alamar1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME) (K911391)Alamar1991-05-08
ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM) (K911390)Alamar1991-05-08
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM) (K911389)Alamar1991-05-08
ANTIMICROBIAL GENTAMICIN (K911305)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL TOBRAMYCIN (K911304)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL. (K911556)Alamar Biosciences Laboratory, Inc.1991-04-22
ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL. (K911555)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN (K911557)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICID (K911559)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL AMPICILLIN (K911185)Alamar Biosciences Laboratory, Inc.1991-04-22
ANTIMICROBIAL AMIKACIN (K911303)Alamar Biosciences Laboratory, Inc.1991-04-18
ANTIMICROBIAL AMPICILLIN/SULBACTAM (K911186)Alamar Biosciences Laboratory, Inc.1991-04-17
ANTIMICROBIAL CEFUROXIME (K911187)Alamar Biosciences Laboratory, Inc.1991-04-17
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K910484)Alamar1991-03-11
EF SYNERGY QUAD MODIFIED (K910242)Remel Co.1991-03-05
ANTIMICROBIAL CEFOPERAZONE (K910345)Alamar1991-02-25
ANTIMICROBIAL CEFTRIAXONE (K910346)Alamar1991-02-25
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS (K904689)Alamar Biosciences Laboratory, Inc.1991-02-07
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K905853)Alamar Biosciences Laboratory, Inc.1991-02-07
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED (K904523)Alamar Biosciences Laboratory, Inc.1990-12-21
EF SYNERGY QUAD (K903589)Remel Co.1990-11-13
FASTIDIOUS MIC PANEL (K901598)Microtech Medical Systems, Inc.1990-11-08
PASCO MIC AND MIC/ID MODIFIED (K902739)Pasco Laboratories, Inc.1990-07-16
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN (K896278)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-03-07
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE (K896566)Medical Specialties, Inc.1990-02-09
SUPPLEMENT TO ANAEROBIC MIC PANEL (K896332)Microtech Medical Systems, Inc.1990-02-05
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K896965)Alamar Biosciences Laboratory, Inc.1990-01-29
PASCO MIC/ID GRAM-POSITIVE PANEL (K895215)Difco Laboratories, Inc.1990-01-29
API UNISCEPT KB (K895796)Analytical Products, Inc.1989-11-13
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K894514)Alamar Biosciences Laboratory, Inc.1989-11-06
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID (K894189)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-10
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS (K894146)Baxter Healthcare Corp1989-09-05
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS (K893977)Baxter Healthcare Corp1989-08-15
ANAEROBIC MIC PANEL (K884831)Microtech Medical Systems, Inc.1989-03-27
MODIFICATION MIC/API UNISCEPT(R) (K884509)Analytical Products, Inc.1988-11-22
MODIFICATION MICRO-MIC (K884510)Analytical Products, Inc.1988-11-22
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL (K883798)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-12
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL (K883800)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-12
SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325 (K883551)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-27
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329 (K883554)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323 (K883548)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332 (K883555)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR STREPTOCOCCUS MIC PANEL #80322 (K883549)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR STAPHYLOCOCCUS MIC #80324 (K883550)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328 (K883552)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331 (K883553)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL (K882477)Pasco Laboratories, Inc.1988-09-08
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS (K883076)Baxter Healthcare Corp1988-09-07
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS (K883394)Baxter Healthcare Corp1988-09-07
SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN (K882909)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-29
SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN (K882911)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM (K882912)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC (K882910)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL (K882299)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-18
SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR (K881716)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-14
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88) (K882301)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-12
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88) (K882300)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-12
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN (K881846)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-08
LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS (K882029)Pasco Laboratories, Inc.1988-07-06
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