Atlas FDA

Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY (K932715)Ciba Corning Diagnostics Corp.1993-12-03
COBAS(R) CORE T3 EIA (K932608)Roche Diagnostic Systems, Inc.1993-12-03
B-HCG HUMAN SERUM CONTROLS (K932479)Pyramid Biological Corp.1993-12-02
REAGENTS FOR COBAS ISE MODULE (K934701)Alko Diagnostic Corp.1993-12-02
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (K932406)Nuclear Diagnostics, Inc.1993-12-02
HCG PREGNANCY ONE STEP TEST STRIP (K934830)Tcpi, Inc.1993-12-02
UROPAPER EIKEN HAG (K932366)Tanabe U.S.A., Inc.1993-11-26
UROPAPER EIKEN AG (K932365)Tanabe U.S.A., Inc.1993-11-26
SPQ MALB CONTROL LEVEL II (K934521)Incstar Corp.1993-11-26
U-TROL LIQUID URINE DIPSTICK CONTROL (K934257)P.T. Meditrol1993-11-26
BUN-300/BUN-500 UREA NITROGEN REAGENT (K934533)Horizon Diagnostics, Inc.1993-11-26
MODEL 400/450 ELECTROLYTE ANALYZER (K932179)Ionetics, Inc.1993-11-17
T3 UPTAKE CHEMILUMINESCENCE ASSAY (K926220)Nichols Institute Diagnostics1993-11-17
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER (K932778)Boehringer Mannheim Corp.1993-11-17
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 (K932049)Stanbio Laboratory1993-11-16
UROPAPER EIKEN 8 (K932367)Tanabe U.S.A., Inc.1993-11-16
UROPAPER EIKEN GK (K932363)Tanabe U.S.A., Inc.1993-11-16
OLYMPUS CREATININE REAGENT (K934361)Olympus Corp.1993-11-16
UROPAPER (K931897)Tanabe U.S.A., Inc.1993-11-16
UROPAPER EIKEN 7 (K932369)Tanabe U.S.A., Inc.1993-11-16
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET (K934039)Intersect Systems, Inc.1993-11-16
UROPAPER EIKEN GP (K932364)Tanabe U.S.A., Inc.1993-11-16
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA (K925093)Beckman Instruments, Inc.1993-11-16
FT4 RADIOIMMUNOASSAY (K934012)Immunotech S.A.1993-11-16
GLUCOSTIX REAGENT STRIPS (K926362)Heraeus Kulzer, Inc.1993-11-10
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) (K930322)Heraeus Kulzer, Inc.1993-11-10
AUTOBEAD THYROID UPTAKE (K930689)Bio-Chem Laboratory Systems, Inc.1993-11-10
CHOLESTECH L.D.X. SYSTEM (K932727)Cholestech Corp.1993-11-09
AIA-PACK E2 ASSAY (K932084)Tosoh Medics, Inc.1993-11-09
IRON/UIBC REAGENT (K932517)Sigma Diagnostics, Inc.1993-11-09
BECKMAN SYNCHRON LACTATE REAGENT (K934271)Beckman-Diagnostic Systems Group1993-11-09
SYNELISA PROGESTERONE (K933128)Elias U.S.A., Inc.1993-11-05
KINGS BAY PRELUDE ONE STEP HCG COMBO KIT (K931698)King'S Bay Intl., Inc.1993-11-05
OLYMPUS CHLORIDE REAGENT, MODIFICATION (K934136)Olympus Corp.1993-11-05
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET (K934143)Crestat Diagnostics, Inc.1993-11-05
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM (K932467)Instrumentation Laboratory CO1993-11-05
ACCESS VITAMIN B12 ASSAY (K933142)Bio-Rad Laboratories, Inc.1993-11-05
AMYLASE REAGENT SET (KINETIC) (K931080)Teco Diagnostics1993-11-05
ELS 1000 (K933548)Bio-Tek Instruments, Inc.1993-10-29
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 (K933437)Baxter Diagnostics, Inc.1993-10-28
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 (K932660)More Diagnostics1993-10-28
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC (K932912)Baxter Diagnostics, Inc.1993-10-28
GENZYME A-AMYLASE TEST REAGENT (K933397)Genzyme Corp.1993-10-28
BECKMAN CHOLESTEROL REAGENT (K934046)Beckman-Diagnostic Systems Group1993-10-28
SYNERMED DIRECT BILIRUBIN REAGENT KIT (K933026)Synermed, Inc.1993-10-28
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL (K932442)Helena Laboratories1993-10-28
DMA AMYLASE PROCEDURE (K931559)Data Medical Associates, Inc.1993-10-28
SIGMA ELECTROLYTE BUFFER (K933695)Sigma Chemical Co.1993-10-22
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY (K933464)Baxter Diagnostics, Inc.1993-10-22
VISTA FOLATE ASSAY (K934121)Syva Co.1993-10-22
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (K933329)King Diagnostics, Inc.1993-10-22
AIA-PACK(R) PROG ASSAY (K933269)Tosoh Medics, Inc.1993-10-22
PROGESTERONE RADIOIMMUNOASSAY KIT (K931228)Immunotech Corp.1993-10-22
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 (K934357)Bio-Rad1993-10-21
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 (K932768)Helena Laboratories1993-10-18
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (K932980)Sigma Diagnostics, Inc.1993-10-18
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 (K934056)Medical Analysis Systems, Inc.1993-10-18
OLYMPUS AMYLASE REAGENT (K931301)Olympus Corp.1993-10-18
SIGMA CRE REAGENT (K933697)Sigma Chemical Co.1993-10-18
AVL 9110PH ANALYZER (K932642)Avl Scientific Corp.1993-10-14
BECKMAN HDL CHOLESTEROL REAGENT (K934045)Beckman Instruments, Inc.1993-10-14
CHEMSTRIP SUPER UA URINE ANALYZER (K934042)Boehringer Mannheim Corp.1993-10-14
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM (K933955)E.I. Dupont DE Nemours & Co., Inc.1993-10-13
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (K933693)Sigma Chemical Co.1993-10-13
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM (K933386)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-10-12
ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) (K933862)Schiapparelli Biosystems, Inc.1993-10-12
ACCESS FOLATE ASSAY (K932887)Beckman Coulter, Inc.1993-10-12
IL TEST GLUCOSE (K931402)Instrumentation Laboratory CO1993-10-12
ACCULYTE CHEMILUMINESCENCE ANALYZER (K921536)Laboratory Technologies, Inc.1993-10-12
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY (K933635)Baxter Diagnostics, Inc.1993-10-08
SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 (K933702)Sigma Chemical Co.1993-10-08
IL TEST URIC ACID (K931350)Instrumentation Laboratory CO1993-10-01
RADIAS FOLATE ENZYME IMMUNOASSAY (K933571)Bio-Rad1993-10-01
ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III (K931907)Anthos Labtec Instruments1993-09-29
MICROTAINER BRAND TUBE WITH EDTA (K931368)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-09-28
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT (K932758)Medix Biotech, Inc.1993-09-28
SYNELISA CORTISOL (K931177)Elias U.S.A., Inc.1993-09-27
CALCIUM TEST ITEM NUMBER 65409 (K932158)Em Diagnostic Systems, Inc.1993-09-27
URIC ACID TEST ITEM NUMBER 65422 (K932162)Em Diagnostic Systems, Inc.1993-09-27
UREA KIT (K923506)Randox Laboratories, Ltd.1993-09-27
ENZYMATIC CO2 REAGENT, MODIFICATION (K932267)Intersect Systems, Inc.1993-09-24
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 (K933435)Baxter Diagnostics, Inc.1993-09-24
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES (K933744)Sa Scientific, Inc.1993-09-24
COBAS CORE FSH EIA (K930304)Roche Diagnostic Systems, Inc.1993-09-21
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES (K932178)Tosoh Medics, Inc.1993-09-21
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 (K932159)Em Diagnostic Systems, Inc.1993-09-21
OLYMPUS CREATININE REAGENT (K931939)Olympus Corp.1993-09-21
ACE CLINICAL CHEMISTRY SYSTEM (K931786)Schiapparelli Biosystems, Inc.1993-09-21
OLYMPUS CHLORID REAGENT, MODIFIED (K932528)Olympus Corp.1993-09-17
HCG MIDSTREAM PREGNANCY TEST (K931997)Mizuho USA, Inc.1993-09-10
AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (K930006)Bio-Chem Laboratory Systems, Inc.1993-09-09
AMP ALKALINE PHOSPHATASE REAGENT KIT (K931986)Synermed, Inc.1993-09-08
CHEMILUMINESCENCE FREE T3 IMMUNOASSAY (K931600)Nichols Institute1993-09-08
UIBC FOR DISCREET RANDOM ACCESS ANALYZER (K932871)Catachem, Inc.1993-09-08
OPUS TOTAL CK (K933675)Pb Diagnostic Systems, Inc.1993-09-08
GLUCOFILM TEST STRIPS (K926360)Heraeus Kulzer, Inc.1993-09-08
SYNERMED GGT REAGENT KIT (K931958)Synermed, Inc.1993-09-08
OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT (K931835)Olympus Corp.1993-09-08
UREA NITROGEN TEST ITEM NUMBER 65408 (K932161)Em Diagnostic Systems, Inc.1993-09-08
OPUS ESTRADIOL (K933066)Pb Diagnostic Systems, Inc.1993-09-08
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