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: Chemistry ×
13,237 results
5689–5712 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 02, 1993
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
K932406 · JNO
Nuclear Diagnostics, Inc.
Chemistry · 203d
Cleared Dec 02, 1993
B-HCG HUMAN SERUM CONTROLS
K932479 · JJX
Pyramid Biological Corp.
Chemistry · 192d
Cleared Dec 02, 1993
REAGENTS FOR COBAS ISE MODULE
K934701 · JIX
Alko Diagnostic Corp.
Chemistry · 63d
Cleared Dec 02, 1993
HCG PREGNANCY ONE STEP TEST STRIP
K934830 · LCX
Tcpi, Inc.
Chemistry · 55d
Cleared Nov 26, 1993
UROPAPER EIKEN AG
K932365 · JIL
Tanabe U.S.A., Inc.
Chemistry · 221d
Cleared Nov 26, 1993
UROPAPER EIKEN HAG
K932366 · JIL
Tanabe U.S.A., Inc.
Chemistry · 221d
Cleared Nov 26, 1993
U-TROL LIQUID URINE DIPSTICK CONTROL
K934257 · JJW
P.T. Meditrol
Chemistry · 87d
Cleared Nov 26, 1993
SPQ MALB CONTROL LEVEL II
K934521 · JJX
Incstar Corp.
Chemistry · 70d
Cleared Nov 26, 1993
BUN-300/BUN-500 UREA NITROGEN REAGENT
K934533 · CDQ
Horizon Diagnostics, Inc.
Chemistry · 70d
Cleared Nov 17, 1993
T3 UPTAKE CHEMILUMINESCENCE ASSAY
K926220 · KHQ
Nichols Institute Diagnostics
Chemistry · 342d
Cleared Nov 17, 1993
MODEL 400/450 ELECTROLYTE ANALYZER
K932179 · JGS
Ionetics, Inc.
Chemistry · 196d
Cleared Nov 17, 1993
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
K932778 · JJQ
Boehringer Mannheim Corp.
Chemistry · 162d
Cleared Nov 16, 1993
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA
K925093 · JJF
Beckman Instruments, Inc.
Chemistry · 405d
Cleared Nov 16, 1993
UROPAPER
K931897 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
K932049 · CIT
Stanbio Laboratory
Chemistry · 203d
Cleared Nov 16, 1993
UROPAPER EIKEN GK
K932363 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
UROPAPER EIKEN GP
K932364 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
UROPAPER EIKEN 8
K932367 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
UROPAPER EIKEN 7
K932369 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
K933425 · DKC
Sigma Diagnostics, Inc.
Chemistry · 126d
Cleared Nov 16, 1993
FT4 RADIOIMMUNOASSAY
K934012 · CEC
Immunotech S.A.
Chemistry · 90d
Cleared Nov 16, 1993
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
K934039 · LBR
Intersect Systems, Inc.
Chemistry · 90d
Cleared Nov 16, 1993
OLYMPUS CREATININE REAGENT
K934361 · CGX
Olympus Corp.
Chemistry · 69d
Cleared Nov 10, 1993
GLUCOSTIX REAGENT STRIPS
K926362 · CGA
Heraeus Kulzer, Inc.
Chemistry · 324d