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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12889–12912 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 02, 1977
PATHONORM H & L
K771439 · JJT
Nyegaard & Co. A/S
Chemistry · 32d
Cleared Sep 02, 1977
MULTISTAT III GLUCOSE TEST
K771464 · CFR
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III LACTIC DEHYDROGENASE
K771465 · CFJ
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466 · CKA
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III ASPARTATE AMINOTRANSFERASE
K771467
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III TRIGLYCERIDE TEST
K771472 · CDT
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Aug 26, 1977
CARDIOZYME CK-MB REAGENTS
K770974
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 87d
Cleared Aug 26, 1977
SMA II
K771336 · JJC
Technicon Instruments Corp.
Chemistry · 39d
Cleared Aug 25, 1977
HEMOX-ANALYZER
K771253 · CHL
3M Company
Chemistry · 45d
Cleared Aug 22, 1977
ALBUMIN TEST, HMA ALBUMIN TEST
K771259 · CIX
Hycel, Inc.
Chemistry · 42d
Cleared Aug 22, 1977
FLAME PHOTOMETER MODEL 460
K771303 · JIH
Corning Medical & Scientific
Chemistry · 38d
Cleared Aug 22, 1977
AUTOZYME IMMOBILIZED ENZYME COIL
K771384 · CFR
Technicon Instruments Corp.
Chemistry · 26d
Cleared Aug 22, 1977
MULTI-CAVITY EQUILIBRIUM CELL
K771434
Techhnilab Instruments, Inc.
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III CPK TEST
K771441 · CGS
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III UREA NITROGEN TEST
K771442 · CDN
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III CREATININE TEST
K771443 · CGX
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
DUAL LAB-LITE LIGHT BOX
K771486 · DJS
Technilab
Chemistry · 21d
Cleared Aug 22, 1977
CK-MB
K771497 · JHT
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Aug 22, 1977
KEM-O-MAT
K771513 · JJF
Coulter Electronics, Inc.
Chemistry · 14d
Cleared Aug 16, 1977
CREATININE ANALYSIS PRODUCTS
K771365 · CGX
Abbott Laboratories
Chemistry · 22d
Cleared Aug 16, 1977
QUALICHECK TM
K771444 · JJS
The London Co.
Chemistry · 15d
Cleared Aug 16, 1977
MICRO SYRINGE & NEEDLE
K771454
Terumo America, Inc.
Chemistry · 12d
Cleared Aug 10, 1977
ELECTROPHORESIS OVEN THERMOMETER
K771323 · JJN
Corning Medical & Scientific
Chemistry · 23d
Cleared Aug 10, 1977
SPINSEP-TBG
K771341 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 22d