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
4729–4752 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 27, 1986
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA
K863164 · JSM
Precision Dynamics Corp.
Microbiology · 9d
Cleared Aug 26, 1986
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
K862638 · LJC
Isolab, Inc.
Microbiology · 47d
Cleared Aug 21, 1986
CELLMATICS RSV DETECTION SYSTEM
K862321 · LKT
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Aug 19, 1986
MODIFIED IDEIA CHLAMYDIA TEST
K861966 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 91d
Cleared Aug 19, 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320 · LJP
Difco Laboratories, Inc.
Microbiology · 62d
Cleared Aug 12, 1986
SEROIDEN STREPTO KIT 'EIKEN'
K861098 · GTZ
Syn-Kit, Inc.
Microbiology · 141d
Cleared Aug 08, 1986
FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
K861716 · GRZ
Whittaker Bioproducts, Inc.
Microbiology · 94d
Cleared Aug 08, 1986
RUBELLA IGM EIA TEST KIT
K862431 · LFX
Labsystems, Inc.
Microbiology · 43d
Cleared Aug 04, 1986
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K862607 · LIO
Boots-Celltech Diagnostics, Inc.
Microbiology · 27d
Cleared Aug 04, 1986
VACUTAINER BRAND AGAR SLANT
K862761 · KZI
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared Aug 01, 1986
REPLIANALYZER
K861958 · LON
Mct Medical, Inc.
Microbiology · 73d
Cleared Aug 01, 1986
PDQ AMEBIASIS
K862473 · KHW
Diamedix Corp.
Microbiology · 32d
Cleared Jul 21, 1986
ENZYGNOST ANTI-CMV IGM TEST
K861363 · LKQ
Behring Diagnostics, Inc.
Microbiology · 102d
Cleared Jul 17, 1986
DISPENS-O-DISC DIFFERENTIATION DISKS PYR
K862570 · JTO
Difco Laboratories, Inc.
Microbiology · 10d
Cleared Jul 16, 1986
GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM
K860498 · LQH
Gen-Probe, Inc.
Microbiology · 156d
Cleared Jul 16, 1986
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
K861379 · LKT
Serono Diagnostics, Inc.
Microbiology · 93d
Cleared Jul 16, 1986
MICRODILUTION PANELS
K862140 · JWY
American Micro Scan
Microbiology · 42d
Cleared Jul 14, 1986
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
K860145 · LFX
Clinical Sciences, Inc.
Microbiology · 180d
Cleared Jul 11, 1986
CANDI-KIT TM
K854672 · JSI
Culture Kits, Inc.
Microbiology · 232d
Cleared Jul 11, 1986
PRECEPT CEFTAZIDIME
K862446 · JWY
Austin Biological Laboratories
Microbiology · 14d
Cleared Jul 11, 1986
PRECEPT CEFTIZOXIME
K862560 · JWY
Austin Biological Laboratories
Microbiology · 8d
Cleared Jul 03, 1986
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM
K860574 · LQG
Gen-Probe, Inc.
Microbiology · 139d
Cleared Jul 03, 1986
BIOTIS HAEMOPHILUS IDENTIFICATION QUAD
K862387 · JSH
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS TCBS AGAR
K862388 · JSI
Otisville Biotech, Inc.
Microbiology · 9d