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
11833–11856 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 27, 1980
TSH RIASSAY
K801691 · JLW
Ria Diagnostics
Chemistry · 35d
Cleared Aug 20, 1980
BMC RIAFLO SYSTEM
K801481 · JJC
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Aug 20, 1980
ULTRAFREE CALCIUM FILTER
K801500 · JRL
Millipore Corp.
Chemistry · 54d
Cleared Aug 20, 1980
PHOTOMETER LP 6
K801562 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
PHOTOMETER LP 3
K801563 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
PHOTOMETER LP 1
K801564 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
CORNING 184 BLOOD GAS TONOMETER
K801599 · LCH
Corning Medical & Scientific
Chemistry · 37d
Cleared Aug 20, 1980
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K801649 · KNK
Eastman Kodak Company
Chemistry · 33d
Cleared Aug 20, 1980
SERALYZER GLUCOSE REAGENT STRIPS
K801663 · CGA
Miles Laboratories, Inc.
Chemistry · 30d
Cleared Aug 20, 1980
SERALYZER GLUCOSE TEST MODULE
K801664 · JQP
Miles Laboratories, Inc.
Chemistry · 30d
Cleared Aug 20, 1980
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
K801665 · JIS
Miles Laboratories, Inc.
Chemistry · 30d
Cleared Aug 20, 1980
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS
K801745 · KZQ
Varian Assoc., Inc.
Chemistry · 23d
Cleared Aug 13, 1980
AGA UV PHOTOMETER
K801499 · JJQ
Syva Co.
Chemistry · 47d
Cleared Aug 13, 1980
QUICK CEPT
K801668 · JHS
Laboratory Diagnostics Co., Inc.
Chemistry · 23d
Cleared Aug 08, 1980
NSI WASH SOLUTION CONCENTRATE
K800587 · JJC
Nobel Scientific Industries, Inc.
Chemistry · 144d
Cleared Jul 28, 1980
YSI MODELS 23C & 23CM HDL & TOTAL CHOLES
K801285 · CHH
Yellow Springs Instrument Co., Inc.
Chemistry · 60d
Cleared Jul 28, 1980
CENTRIFICHEM SYSTEM MANAGER
K801438 · JQP
Union Carbide Corp.
Chemistry · 39d
Cleared Jul 21, 1980
TOTAL PROTEIN TEST
K801061 · CEK
Environmental Chemical Specialties
Chemistry · 76d
Cleared Jul 21, 1980
FOLATE RADIOASSAY KIT
K801198 · CGN
Calbiochem-Behring Corp.
Chemistry · 63d
Cleared Jul 21, 1980
ALBUMIN NEPHELOMETRIC ASSAY
K801362 · JQX
J.T. Baker Chemical Co.
Chemistry · 42d
Cleared Jul 21, 1980
BLOOD GAS CONTROL PROD. NO. BG-1, BG-2
K801449 · JJS
Health Diagnostics Corp.
Chemistry · 28d
Cleared Jul 14, 1980
COBAS CK-NAC REAGENT
K801299 · CGS
Roche Analytical Instruments, Inc.
Chemistry · 42d
Cleared Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318 · JHX
Helena Laboratories
Chemistry · 36d
Cleared Jul 14, 1980
BECKMAN MODEL 42 SPECTROPHOTOMETER
K801373 · JJQ
Beckman Instruments, Inc.
Chemistry · 34d