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Microbiology

6,936 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
SAS SHIGELLA SONNEI FORM II ANTISERUM (K961537)Sa Scientific, Inc.1996-05-31
DIRECTIGEN MENINGITIS COMBO TEST (K952791)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-05-30
IMX SELECT CHLAMYDIA (K936054)Abbott Laboratories1996-05-30
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL (K961042)Dade Microscan, Inc.1996-05-30
PREMIER HSV PLUS (K953839)Meridian Diagnostics, Inc.1996-05-23
VISUWELL REAGIN II (K952802)Biomira Diagnostics, Inc.1996-05-23
BACTEC(R) 9000TB SYSTEM (K946268)Becton Dickinson Diagnostic Instrument Systems1996-05-21
HELISAL RAPID BLOOD TEST (K953686)Cortecs, Ltd.1996-05-21
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) (K961528)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM (K961551)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM (K961532)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM (K961546)Sa Scientific, Inc.1996-05-20
ETEST SUBMISSION FOR VANCOMYCIN (K960990)Ab Biodisk1996-05-20
SAS SHIGELLA BOYDII TYPE 12 ANTISERUM (K961529)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM (K961535)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) (K961534)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM (K961549)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM (K961538)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM (K961554)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM (K961548)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM (K961543)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM (K961553)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM (K961558)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM (K961539)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 14 ANTISERUM (K961547)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 13 ANTISERUM (K961531)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 8 ANTISERUM (K961541)Sa Scientific, Inc.1996-05-20
ETEST SUBMISSION FOR IMIPENEM (K960989)Ab Biodisk1996-05-20
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM (K961533)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM (K961559)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA SONNEI GROUP D ANTISERUM (K961540)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM (K961556)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM (K961542)Sa Scientific, Inc.1996-05-20
CYTOQUANT VIRAL TRANSPORT MEDIUM (K961756)Proteins Intl., Inc.1996-05-17
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (K961755)Proteins Intl., Inc.1996-05-17
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY (K954318)Abbott Laboratories1996-05-14
TOXOSTAT (K944867)Bio-Whittaker, Inc., A Cambrex Co.1996-05-14
LCX NEISSERIA GONORRHOEAE ASSAY (K935833)Abbott Laboratories1996-05-06
IMMUNO DOT BORRELIA DOT BLOT G TEST (K953682)Genbio1996-05-03
MMUNO DOT BORRELIA DOT BLOT M TEST (K953683)Genbio1996-05-03
EBNA IGG EIA TEST SYSTEM (K951549)Immunoprobe, Inc.1996-04-29
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (K961148)Difco Laboratories, Inc.1996-04-26
M. CAT BUTYRATE DISK (K960996)Hardy Diagnostics1996-04-18
IMMUNOCARD TOXIN A (K955859)Meridian Diagnostics, Inc.1996-04-18
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE (K951359)Bayer Corp.1996-04-15
CARDS Q.S. STREP A (K955108)Quidel Corp.1996-04-15
HAEMOPHILUS TEST MEDIUM (HTM) (K952595)Clinical Standards Laboratories, Inc.1996-04-10
ACCESS RUBELLA IGG (K954687)Bio-Rad Laboratories, Inc.1996-04-09
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (K960366)Accumed Intl., Inc.1996-04-09
CEFEPIME, 30 MCG, SENSI-DISC (K961188)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-04-05
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K960420)Becton Dickinson Microbiology Systems1996-04-04
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (K960997)Starplex Scientific, Inc.1996-04-03
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (K960235)Accumed Intl., Inc.1996-03-27
MUELLER HINTON AGAR WITH 2% NACI (K960313)Remel, L.P.1996-03-25
BINAX STREP A TEST (K960712)Binax, Inc.1996-03-22
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951799)Light Diagnostics1996-03-20
VARICELISA, MODIFICATION (K943843)Biowhittaker Molecular Applications, Inc.1996-03-14
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (K952095)Biomerieux Vitek, Inc.1996-03-12
SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM (K960160)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM (K960129)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM (K960461)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM (K960130)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM (K960147)Sa Scientific, Inc.1996-03-12
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (K960220)Sensititre , Ltd.1996-03-11
SAS SALMONELLA H P ANTISERUM (K960136)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM (K960163)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM (K960124)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM (K960465)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM (K960463)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H M ANTISERUM (K960135)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM (K960162)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM (K960127)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM (K960134)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM (K960138)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 27 ANTISERUM (K960145)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H Z10 ANTISERUM (K960137)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 12 ANTISERUM (K960152)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM (K960140)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 46 ANTISERUM (K960460)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM (K960123)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM (K960150)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM (K960459)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM (K960462)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM (K960126)Sa Scientific, Inc.1996-03-06
SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM (K960153)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM (K960142)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM (K960149)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM (K960458)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM (K960125)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM (K960161)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H U ANTISERUM (K960132)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H G,P,U ANTISERUM (K960333)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H F ANTISERUM (K960133)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z15 ANTISERUM (K960610)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z28 ANTISERUM (K960331)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H G ANTISERUM (K960131)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z23 ANTISERUM (K960603)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H POLY A-Z ANTISERUM (K960335)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z32 ANTISERUM (K960609)Sa Scientific, Inc.1996-03-04
GIBSON ID-M. CAT. (K955826)Gibson Laboratories, Inc.1996-02-29
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