Atlas FDA

JSI

285 FDA 510(k) clearances · Product code

23 daysmedian time to decision
67 days90th percentile
285clearances measured

FDA profile

Official device name
Culture Media, Selective And Differential
Device class
Class I (low risk)
Regulation
21 CFR 866.2360
Medical specialty
Microbiology
Adverse events (MAUDE)
1998: 1 · 2021: 83 · 2022: 88 · 2023: 36 · 2024: 22 · 2025: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BBL CHROMAGAR 0157 (K070691)Becton, Dickinson & CO2007-11-20
DIPSTREAK (K974428)Novamed , Ltd.1998-07-30
LISTERIA SELECTIVE ENRICHMENT MEDIUM (K891593)Oxoid U.S.A., Inc.1989-06-09
DENTOCULT SM-STRIP MUTANS (K890199)Orion Corp.1989-03-02
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (K882182)Lakewood Biochemical Co., Inc.1988-06-06
TRICHOMONAS BROTH (K881556)Acumedia Manufacturers, Inc.1988-04-18
XL AGAR BASE (K881572)Acumedia Manufacturers, Inc.1988-04-18
SELENITE BROTH (K881576)Acumedia Manufacturers, Inc.1988-04-18
MODIFIED SELECTIVE STREPTOCOCCUS AGAR (K881577)Acumedia Manufacturers, Inc.1988-04-18
SELECTIVE STREPTOCOCCUS AGAR (K881575)Acumedia Manufacturers, Inc.1988-04-18
TINSDALE AGAR BASE (K881555)Acumedia Manufacturers, Inc.1988-04-18
LOWENSTEIN-JENSEN, SELECTIVE (K880125)Hardy Media1988-03-31
CORN MEAL W/POLYSORBATE 80 (K880108)Hardy Media1988-03-30
DERMATOPHYTE TEST MEDIUM (K880132)Hardy Media1988-03-30
ATS MEDIA (K880130)Hardy Media1988-03-30
SPECIALTY MEDIA (K873259)Central Media1987-11-06
QUAD PLATE (4 DIFFERENT MEDIA) (K874344)Lakewood Biochemical Co., Inc.1987-11-06
CORYNEBACTERIA ISOLATION MEDIA (K873260)Central Media1987-11-06
STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA (K873258)Central Media1987-11-06
MYCOLOGICAL MEDIA (K873269)Central Media1987-11-04
MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS (K873264)Central Media1987-10-28
DIFFERENTIAL MEDIA (K873262)Central Media1987-10-28
ENTERIC ISOLATION MEDIA (K873261)Central Media1987-10-28
MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION (K873265)Central Media1987-10-28
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 (K873481)Lakewood Biochemical Co., Inc.1987-10-08
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330 (K873329)Lakewood Biochemical Co., Inc.1987-10-02
MANNITOL SALT AGAR (MSA) PRODUCT #P1706 (K873227)Lakewood Biochemical Co., Inc.1987-09-23
MACCONKEY AGAR - PRODUCT #P1606 (K873223)Lakewood Biochemical Co., Inc.1987-09-23
EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309 (K873225)Lakewood Biochemical Co., Inc.1987-09-23
LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507 (K873228)Lakewood Biochemical Co., Inc.1987-09-23
XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601 (K873226)Lakewood Biochemical Co., Inc.1987-09-23
DENTOCULT-SM CULTURE-PADDLE (K872301)Orion Corp.1987-09-11
MACCONKEY AGAR - PRODUCT #P1606 (K873055)Lakewood Biochemical Co., Inc.1987-08-24
IAFP MANNITOL NACL (K872675)I.A.F. Production, Inc.1987-08-11
IAFP BILE ESCULIN AZIDE AGAR (K872672)I.A.F. Production, Inc.1987-08-11
IAFP BILE ESCULIN AGAR (K872683)I.A.F. Production, Inc.1987-08-11
IAFP S.S. AGAR (K872682)I.A.F. Production, Inc.1987-08-11
IAFP X.L.D. AGAR (K872669)I.A.F. Production, Inc.1987-08-11
SORBITOL MACCONKEY AGAR NO. 3 CM 813 (K872956)Oxoid U.S.A., Inc.1987-08-10
MACCONKEY W/SORBITOL (K872188)Remel Co.1987-06-24
ORICULT-N CULTURE-PADDLE (K872058)Orion Corp.1987-06-10
POTATO DEXTROSE AGAR (K870643)Hardy Media1987-04-14
CETRIMIDE SELECTIVE AGAR (K870640)Hardy Media1987-04-14
BRILLIANT GREEN AGAR (K870644)Hardy Media1987-04-14
BACTEROIDES BILE ESCULIN AGAR (K870638)Hardy Media1987-04-14
STAPHYLOCOCCUS 110 AGAR (K870648)Hardy Media1987-04-14
ANAEROBIC LKV BLOOD AGAR (K871088)bioMerieux, Inc.1987-04-03
BRILLIANT GREEN AGAR (K871094)bioMerieux, Inc.1987-04-03
HEKTOEN ENTERIC AGAR (K864242)Mds Laboratories, Inc.1987-03-31
MACCONKEY AGAR (K864243)Mds Laboratories, Inc.1987-03-31
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS (K870502)Clinical Convenience Products, Inc.1987-02-26
P1012 BE AGAR (K870341)Lakewood Biochemical Co., Inc.1987-02-13
Z2017, BEA/CNA 5%SB BIPLATE (K870340)Lakewood Biochemical Co., Inc.1987-02-13
P4802 BEA (K870339)Lakewood Biochemical Co., Inc.1987-02-13
T1365 (BIRD SEED AGAR SLANT) (K870057)Lakewood Biochemical Co., Inc.1987-02-04
CULTURIA MACCONKEY-MUG/CLED SYSTEMS (K864764)Clinical Convenience Products, Inc.1986-12-29
CANDIDA BROM CRESOL GREEN AGAR (K864077)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-10-31
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS (K863525)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR (K863519)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
CANDI-KIT TM (K854672)Culture Kits, Inc.1986-07-11
BIOTIS ACETAMIDE AGAR (K862389)Otisville Biotech, Inc.1986-07-03
BIOTIS MITIS SALIVARIUS (K862394)Otisville Biotech, Inc.1986-07-03
BIOTIS TCBS AGAR (K862388)Otisville Biotech, Inc.1986-07-03
BIOTIS DESOXYCHOLATE AGAR (K862391)Otisville Biotech, Inc.1986-07-03
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (K862425)Gibco Laboratories Life Technologies, Inc.1986-07-02
OFPBL (K860707)Remel Co.1986-03-11
BIOTIS SF BROTH (K860386)Otisville Biotech, Inc.1986-02-24
BIOTIS BISMUTH SULFITE AGAR (K860402)Otisville Biotech, Inc.1986-02-24
BIOTIS KF STREPTOCOCCUS AGAR (K860388)Otisville Biotech, Inc.1986-02-24
BIOTIS MAC-MUG (K860385)Otisville Biotech, Inc.1986-02-24
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (K855205)Hana Biologics, Inc.1986-02-05
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8 (K855110)Gibco Laboratories Life Technologies, Inc.1986-01-07
HEKTOEN ENTERIC AGAR (K854449)R. Kent Richards, Inc.1985-11-18
MANNITOL SALT AGAR (K854452)R. Kent Richards, Inc.1985-11-18
BILE ESCULIN AZIDE AGAR (K854450)R. Kent Richards, Inc.1985-11-18
TERGITOL 7 AGAR (K853691)Micro Media Laboratories1985-09-17
APL SIMMONS CITRATE AGAR (K853617)Apl Medical Supplies1985-09-16
APL XYLOSE LYSINE DEOXYCHOLATE AGAR (K853611)Apl Medical Supplies1985-09-12
STAPH KIT (K853488)Culture Kits, Inc.1985-08-28
APL BIGGY AGAR(NICKERSON) (K853226)Apl Medical Supplies1985-08-19
APL HEKTOEN ENTERIC AGAR (K853235)Apl Medical Supplies1985-08-19
APL 6.5% SODIUM CHLORIDE BROTH (K853229)Apl Medical Supplies1985-08-19
APL MACCONKEY AGAR (K853234)Apl Medical Supplies1985-08-19
APL MANNITOL SALT AGAR (K853232)Apl Medical Supplies1985-08-19
APL LEVINE EMB AGAR (K853225)Apl Medical Supplies1985-08-19
APL SALMONELLA-SHIGELLA AGAR (K853228)Apl Medical Supplies1985-08-19
AEROMONAS AGAR(XDCA) (K852789)Gibco Laboratories Life Technologies, Inc.1985-07-19
DERM-KIT (K852480)Culture Kits, Inc.1985-07-09
SF BROTH (K851594)Preferred Micro-Media1985-05-14
XYLOSE LYSINE DESOXYCHOLATE AGAR (K851603)Preferred Micro-Media1985-05-08
BILE ESCULIN AGAR (K851578)Preferred Micro-Media1985-05-08
BILE ESCULIN AZIDE AGAR (K851577)Preferred Micro-Media1985-05-08
HEKTOEN ENTERIC AGAR (K851583)Preferred Micro-Media1985-05-02
DERMATOPHYTE TEST MEDIUM (K851581)Preferred Micro-Media1985-05-02
MACCONKEY AGAR (K851586)Preferred Micro-Media1985-04-30
LEVINE EMB AGAR (K851584)Preferred Micro-Media1985-04-30
MANNITOL SALT AGAR (K851585)Preferred Micro-Media1985-04-30
SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC (K850723)Rapid City Regional Hospital, Inc.1985-03-22
EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5% (K850720)Rapid City Regional Hospital, Inc.1985-03-22
SELECTIVE CULTURE MEDIUM (K850736)Roseville Medical Laboratoriesu1985-03-20
Next →

Track JSI automatically

Every clearance here is in the API, with alerts when new ones post.