FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
4849–4872 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 06, 1986
KULTSURE (CATALOGUE NO. M200)
K860655 · LIO
Ncs Diagnostics, Inc.
Microbiology · 13d
Cleared Mar 04, 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · JSS
Roche Diagnostic Systems, Inc.
Microbiology · 231d
Cleared Mar 04, 1986
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278 · JWX
American Micro Scan
Microbiology · 131d
Cleared Mar 04, 1986
API 50 CHB (CULTURE MEDIA)
K854732 · JST
Dms Products, Inc.
Microbiology · 99d
Cleared Mar 04, 1986
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
K860153 · JTN
Oxoid U.S.A., Inc.
Microbiology · 48d
Cleared Mar 04, 1986
INSTA KIT FOR GROUP A STREP ID
K860247 · GTZ
Mead Johnson & Co.
Microbiology · 39d
Cleared Mar 04, 1986
ROTALEX
K860529 · LIQ
Orion Corp.
Microbiology · 21d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M210)
K860656 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M240)
K860657 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M250)
K860658 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 03, 1986
DETECTACULT
K854619 · KHE
Immunostics Co., Inc.
Microbiology · 105d
Cleared Mar 03, 1986
V-TREND KIT STAPH LATEX TEST
K855220 · JWX
Texas Immunology, Inc.
Microbiology · 63d
Cleared Mar 03, 1986
QUADRA-TITER I.D.
K860208 · JSS
Microtech Medical Systems, Inc.
Microbiology · 40d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSITIVITY DISCS
K860527 · JTN
Difco Laboratories, Inc.
Microbiology · 20d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSI DISC
K860536 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Mar 03, 1986
POLYPET
K860617 · JTC
Instrumed, Inc.
Microbiology · 12d
Cleared Feb 24, 1986
LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)
K854719 · LIO
Xsirius Scientific, Inc.
Microbiology · 94d
Cleared Feb 24, 1986
BIOTIS CLOSTRIDIUM DIFFICILE AGAR
K860383 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MODIFIED THAYER MARTIN
K860384 · JTY
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MAC-MUG
K860385 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SF BROTH
K860386 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS KF STREPTOCOCCUS AGAR
K860388 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN
K860390 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT
K860391 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d