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
4681–4704 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 06, 1996
N/T PROTEIN CONTROL SL
K964065 · JJY
Behring Diagnostics, Inc.
Chemistry · 27d
Cleared Nov 05, 1996
ANTHOS PHACTS VERSION MICROPLATE READER
K962113 · JJQ
Columbia Bioscience, Inc.
Chemistry · 158d
Cleared Nov 05, 1996
ACS CORTISOL IMMUNOASSAY
K962559 · JFT
Ciba Corning Diagnostics Corp.
Chemistry · 127d
Cleared Nov 01, 1996
ALPCO/MERCODIA INSULIN ELISA
K963911 · CFP
American Laboratory Products Co., Ltd.
Chemistry · 32d
Cleared Nov 01, 1996
HEMOCUE GLUCOTROL
K964053 · JJX
Direct Solutions
Chemistry · 32d
Cleared Oct 31, 1996
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K963292 · CIC
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 30, 1996
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
K963543 · JIX
Sigma Diagnostics, Inc.
Chemistry · 56d
Cleared Oct 30, 1996
VISUALINE COMBO V (COCAINE/THC) TEST
K963606 · LDJ
Sun Biomedical Laboratories, Inc.
Chemistry · 51d
Cleared Oct 30, 1996
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
K963827 · CDP
Abbott Laboratories
Chemistry · 36d
Cleared Oct 30, 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
K963833 · CDP
Abbott Laboratories
Chemistry · 36d
Cleared Oct 29, 1996
PICO MODELS 30, 50, 70
K962158 · JKA
Radiometer America, Inc.
Chemistry · 147d
Cleared Oct 29, 1996
MINI SAMPLE PROCESSOR
K962859 · JQW
Cavro Scientific Instruments, Inc.
Chemistry · 99d
Cleared Oct 29, 1996
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
K963533 · JIX
Sigma Diagnostics, Inc.
Chemistry · 55d
Cleared Oct 28, 1996
RADIAS GALT TEST
K961432 · JJX
Bio-Rad
Chemistry · 196d
Cleared Oct 25, 1996
GLUCOSE (HEXOKINASE) KIT
K953210 · CFR
Randox Laboratories, Ltd.
Chemistry · 473d
Cleared Oct 25, 1996
RAPID ELECTROPHORESIS ANALYZER
K960571 · JHO
Helena Laboratories
Chemistry · 260d
Cleared Oct 24, 1996
CSF/URINE TOTAL PROTEIN
K961864 · CEK
Teco Diagnostics
Chemistry · 163d
Cleared Oct 24, 1996
EML105 ELECTROLYTE METABOLITE ANALYZER
K962334 · JGS
Radiometer America, Inc.
Chemistry · 129d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS BUN REAGENT
K963537 · LFP
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS CO2 ACID REAGENT
K963541 · JFL
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 24, 1996
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
K963627 · JGS
Roche Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Oct 24, 1996
ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
K963734 · CGZ
Alko Diagnostic Corp.
Chemistry · 56d
Cleared Oct 23, 1996
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · LBS
Boehringer Mannheim Corp.
Chemistry · 68d
Cleared Oct 21, 1996
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
K962931 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 84d