Atlas FDA

JTO

244 FDA 510(k) clearances · Product code

39 daysmedian time to decision
119 days90th percentile
244clearances measured

FDA profile

Official device name
Discs, Strips And Reagents, Microorganism Differentiation
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
Adverse events (MAUDE)
1998: 1 · 2001: 2 · 2015: 59 · 2016: 44 · 2017: 42 · 2023: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352)Ameritek Research, LLC2005-09-01
PYR SWAB (K970832)Remel, Inc.1997-04-24
GRAM SWAB (K970834)Remel, Inc.1997-04-17
INDOLE SWAB (K970833)Remel, Inc.1997-04-02
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (K970009)Microbiologics, Inc.1997-02-06
IDS RAPID CB PLUS SYSTEM (K962966)Innovative Diagnostic Systems, Inc.1996-10-08
COLISCREEN (K961191)Hardy Diagnostics1996-06-17
M. CAT BUTYRATE DISK (K960996)Hardy Diagnostics1996-04-18
GIBSON ID-M. CAT. (K955826)Gibson Laboratories, Inc.1996-02-29
DRYSLIDE CARTARRHALIS (K954783)Difco Laboratories, Inc.1996-02-06
LYFO(TM) DIFFERIENTAL DISK-PYR (K954812)Microbiologics, Inc.1995-12-20
GIBSON ID A.E. TEST (K953247)Gibson Laboratories, Inc.1995-11-20
LYFO(TM) DIFFERENTIAL DISK (K951889)Microbiologics, Inc.1995-08-24
B-L RED(TM) DISCS (K950346)Oxis Intl., Inc.1995-05-05
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN (K945883)Microbiologics, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE (K945882)Microbiologics, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-SPS (K945880)Microbiologics, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK (K945881)Microbiologics, Inc.1995-04-24
SWABZYME OXIDASE (K934130)E-Y Laboratories, Inc.1994-09-14
B-LACTAMASE REAGENT TUBES (K940161)E-Y Laboratories, Inc.1994-09-09
GONOCHEK-II, MODIFICATION (K934125)E-Y Laboratories, Inc.1994-09-09
GONOCHEK II REAGENT TUBES (K940162)E-Y Laboratories, Inc.1994-09-09
STREP-A-CHEK(TM) REAGENT STRIPS (K940020)E-Y Laboratories, Inc.1994-08-26
EY-20 REAGENT TUBES (K940124)E-Y Laboratories, Inc.1994-08-26
STREP-A-CHEK (K934129)E-Y Laboratories, Inc.1994-08-26
STREP-SURE A/E (K941111)Clinical Standards Laboratories, Inc.1994-08-02
DISPENS-O-DISC(TM) NITROCEFIN (K941016)Difco Laboratories, Inc.1994-06-30
BACTICARD STREP (K936021)Remel Co.1994-05-20
SERIM PYLORITEK REAGENT STRIPS (K936034)Serim Research Corp.1994-04-21
BACTICARD E. COLI (K934986)Remel Co.1994-02-23
PYR TEST KIT (K931865)Hardy Diagnostics1993-12-15
VISI-SPOT (K932752)J.S. Medical Assoc.1993-11-05
BACTICARD STREP (K933514)Remel Co.1993-10-28
NINHYDRIN REAGENT (K931862)Hardy Diagnostics1993-06-15
CATALASE REAGENT (K931414)Hardy Diagnostics1993-05-12
OXYSTRIP (K930693)Hardy Diagnostics1993-05-12
FERRIC CHLORID REAGENT, 10% (K931413)Hardy Diagnostics1993-05-11
BACTIDROP(TM) MUCAP (K930878)Remel Co.1993-05-11
VOGUES-PROSKAUER REAGENT A & B (K930720)Hardy Diagnostics1993-04-23
NITRATE REAGENTS A, B AND C (K930717)Hardy Diagnostics1993-04-23
INDOLE SPOT & INDOLE KOVACS REAGENT (K930718)Hardy Diagnostics1993-04-23
BBL NITRATE A, B REAGENT DROPPERS (K926255)Becton Dickinson Microbiology Systems1993-01-26
BBL NINHYDRIN REAGENT DROPPERS (K926256)Becton Dickinson Microbiology Systems1993-01-26
BBL PYR REAGENT DROPPERS (K926254)Becton Dickinson Microbiology Systems1993-01-26
DRYSLIDE(TM) INDOLE (K925747)Difco Laboratories, Inc.1993-01-15
INDOXYL ACETATE DISK (K923700)Remel Co.1992-10-05
LAP DISK (K923827)Remel Co.1992-09-28
BACTIDROP INDOLE (ERLICH'S) (K920973)Remel Co.1992-06-19
DRYSLIDE(TM), PYR (K921583)Difco Laboratories, Inc.1992-06-19
BACTIDROP NINHYDRIN (K920971)Remel Co.1992-05-22
BACTIDROP PYR (K920972)Remel Co.1992-05-22
NIACIN CONTROL DISKS (K920257)Remel Co.1992-04-22
BACTIDROP(TM) VOGES-PROSKAUER B (K913007)Remel Co.1991-09-23
BACTIDROP(TM) FERRIC CHLORIDE (10%) (K913002)Remel Co.1991-09-23
BACTIDROP(TM) DOBELL & O'CONNOR IODINE (K913006)Remel Co.1991-09-23
BACTIDROP(TM) OXIDASE (K913008)Remel Co.1991-09-23
BACTIDROP(TM) VOGES-PROSKAUER A (K913003)Remel Co.1991-09-23
BACTIDROP(TM) NITRATE A (K913011)Remel Co.1991-09-19
BACTIDROP (TM) NITRATE B (K913010)Remel Co.1991-09-19
BACTIDROP(TM) INDOLE (KOVACS) (K913009)Remel Co.1991-09-18
BACTIDROP(TM) DESOXYCHOLATE (10%) (K913001)Remel Co.1991-09-18
BACTIDROP(TM) SPOT INDOLE (K913004)Remel Co.1991-09-18
BBL(R) DMACA INDOLE REAGENT DROPPERS (K912480)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-08-23
LAP DISCS (K905472)Carr-Scarborough Microbiologicals, Inc.1991-02-27
M. CAT. BUTYRATE DISC (K905666)Carr-Scarborough Microbiologicals, Inc.1991-02-26
NITRATE DISK (K905163)Remel Co.1991-02-20
VANCOMYCIN DISK-5 MCG (K905151)Remel Co.1991-01-25
CATARRHALIS TEST STRIP (K902595)Remel Co.1990-10-02
DMAC INDOLE REAGENT (K902640)Api Analytab Products1990-07-16
DRYSLIDE, BETA-LACTAMASE (K901784)Difco Laboratories, Inc.1990-06-20
PATHODX PYR KIT (K902037)Diagnostic Products Corp.1990-06-01
DMAC INDOLE REAGENT (K901390)Analytical Products, Inc.1990-04-16
DIFCO OXIDASE DRYSLIDE (K896398)Difco Laboratories, Inc.1989-12-18
ROSCO PYRR (K894221)Pro-Lab, Inc.1989-09-28
JAMES REAGENT (K890625)Dms Products, Inc.1989-02-17
PRO DISCS (K882630)Carr-Scarborough Microbiologicals, Inc.1989-02-16
ALN DISCS (K882636)Carr-Scarborough Microbiologicals, Inc.1989-02-16
B. CAT CONFIRM (K880694)Scott Laboratories, Inc.1988-06-16
PYR/ESCULIN DISK (K880950)Remel Co.1988-04-01
MUG-INDOLE DISC (K874933)Scott Laboratories, Inc.1988-01-05
IDENTICULT-BL (K873509)Scott Laboratories, Inc.1987-10-15
CONTROLCHEK II(TM) (K873034)Petra Biomedical Products, Inc.1987-08-19
LD PRESUMPTO QUAD (K871907)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-28
CONTROLCHEK(TM) (K871445)Petra Biomedical Products, Inc.1987-04-29
GEN-PROBE BETA-LACTAMASE TEST KIT (K870422)Gen-Probe, Inc.1987-04-21
CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION (K870561)Diversified Diagnostic Industries1987-04-21
CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS (K870410)Diversified Diagnostic Industries1987-04-21
CHROMAGEN TEST FOR GROUP A STREP (K870409)Diversified Diagnostic Industries1987-04-15
SPOTTEST 10% SODIUM DESOXYCHOLATE (K870716)Difco Laboratories, Inc.1987-04-03
SPOTTEST MICRODASE (K870717)Difco Laboratories, Inc.1987-04-03
GARNERELLA VAGINALIS IDENTIFICATION KIT (K864244)Mds Laboratories, Inc.1987-03-31
SPOTTEST PYR REAGENT (K870449)Difco Laboratories, Inc.1987-02-26
ONPG SOLUTION (K863601)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
NEIS NZY (K863216)Carr-Scarborough Microbiologicals, Inc.1986-09-15
DISPENS-O-DISC DIFFERENTIATION DISKS PYR (K862570)Difco Laboratories, Inc.1986-07-17
D'ALA RAPID TEST (K861889)Pro-Lab, Inc.1986-06-03
HIPPURATE HYDROLYSIS TEST (K861888)Pro-Lab, Inc.1986-06-03
SENSITITRE AUTO ID PLATE, AP70 (K861058)Gibco Laboratories Life Technologies, Inc.1986-05-20
MACCONKEY W/MUG (K861259)Remel Co.1986-04-11
DIFFERENTIATION DISKS VANCOMYCIN 5 MCG (K860563)Difco Laboratories, Inc.1986-03-11
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