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
13057–13080 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 05, 1977
BUN, ENZYMATIC
K770315 · CDQ
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT GOT, ENZYME
K770318 · CIT
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT CPK, ENZYME
K770319 · CGS
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
METER, IV PH, MODEL ZEROMATIC
K770351 · JQY
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
GLUCOSE REAGENT, ENZYMATIC
K770311 · CFR
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
REAGENT GPT, ENZYME
K770314 · CKA
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
ALKALINE PHOSPHATASE ENZYMATIC
K770316 · CJE
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 30, 1977
GLUCOSE TRINDER, ENZYMATIC
K770317 · CGA
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Mar 21, 1977
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · KQO
Miles Laboratories, Inc.
Chemistry · 89d
Cleared Mar 21, 1977
MEGA-DIASTIX
K761310 · JIL
Miles Laboratories, Inc.
Chemistry · 88d
Cleared Mar 21, 1977
VITAMIN B12 RADIOASSAY
K761321 · CDD
Kallestad Laboratories, Inc.
Chemistry · 84d
Cleared Mar 21, 1977
MT II SYSTEM - SERUM ALBUMIN
K761329 · CIX
Technicon Instruments Corp.
Chemistry · 84d
Cleared Mar 16, 1977
CENTRIA T4 RIA
K761272 · CDX
Clinical Diagnostics, Inc.
Chemistry · 86d
Cleared Mar 16, 1977
CHEMSTRIP G
K770271 · JIL
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Mar 10, 1977
SPECTROPHOTOMETERS, INFRARED MODELS X99
K770278 · JJQ
The Perkin-Elmer Corp.
Chemistry · 24d
Cleared Mar 10, 1977
SPECTROPHOTOMETER, MODEL 597 IR
K770288 · JJQ
The Perkin-Elmer Corp.
Chemistry · 24d
Cleared Mar 01, 1977
PIPETTOR, 400, CENTRIFICHEM SYSTEM
K770193 · JQW
Universal Instruments Corp.
Chemistry · 32d
Cleared Mar 01, 1977
AUTO-ENZYMATIC GLUCOSE
K770229 · CFR
Harleco
Chemistry · 22d
Cleared Mar 01, 1977
URIC ACID TEST, BMC AUTOFLO
K770272 · KNK
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Mar 01, 1977
TEST, AMMONIA, BMC REAGENTSET
K770273 · JIF
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Mar 01, 1977
CHOLESTEROL STANDARDS
K770277 · JIT
Worthington Biochemical Corp.
Chemistry · 15d
Cleared Feb 25, 1977
CHOLESTEROL TEST
K770265 · CHH
Sclavo, Inc.
Chemistry · 14d
Cleared Feb 24, 1977
TRI-CON TRIGLYCERIDGE REAGENTS
K761283 · JGY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 66d
Cleared Feb 24, 1977
COMPU-PET 300
K761290 · JQW
Nuclear Medical Laboratories, Inc.
Chemistry · 65d