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
5161–5184 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 14, 1995
PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM
K952279 · CGA
Medisense, Inc.
Chemistry · 64d
Cleared Jun 13, 1995
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
K951189 · JJE
Beckman Instruments, Inc.
Chemistry · 89d
Cleared Jun 13, 1995
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY
K951796 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 55d
Cleared Jun 13, 1995
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
K952075 · JLS
Bayer Corp.
Chemistry · 41d
Cleared Jun 09, 1995
ABBOTT PROJECT I, SPECTRUM
K945566 · JJE
Abbott Laboratories
Chemistry · 231d
Cleared Jun 09, 1995
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
K945800 · JQB
Diagnostic Chemicals , Ltd.
Chemistry · 193d
Cleared Jun 09, 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K951631 · LFM
Bayer Corp.
Chemistry · 63d
Cleared Jun 06, 1995
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
K944999 · JJX
More Diagnostics
Chemistry · 236d
Cleared Jun 01, 1995
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
K950727 · CGA
Lifescan, Inc.
Chemistry · 105d
Cleared Jun 01, 1995
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
K951058 · CFR
Heraeus Kulzer, Inc.
Chemistry · 86d
Cleared Jun 01, 1995
EMIT 2000 DIGOXIN ASSAY
K951755 · KXT
Syva Co.
Chemistry · 45d
Cleared May 26, 1995
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE
K944083 · JKA
Sherwood Medical Co.
Chemistry · 277d
Cleared May 25, 1995
CR PERFECT
K950142 · CGX
Chimera Research & Chemical, Inc.
Chemistry · 132d
Cleared May 24, 1995
MINI S.F.T. (URINE PRESERVATIVE)
K943466 · LXG
Cambridge Diagnostic Products, Inc.
Chemistry · 343d
Cleared May 17, 1995
IMX ESTRADIOL
K951629 · JIS
Abbott Laboratories
Chemistry · 61d
Cleared May 16, 1995
ORTHO ALT MICROWELL TEST SYSTEM
K941192 · CKD
Ortho Diagnostic Systems, Inc.
Chemistry · 428d
Cleared May 16, 1995
ACE(TM) CEDIA(R) FERRITIN ASSAY
K950393 · JMG
Schiapparelli Biosystems, Inc.
Chemistry · 104d
Cleared May 15, 1995
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
K950128 · CEK
Emd Chemicals, Inc.
Chemistry · 123d
Cleared May 15, 1995
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
K950524 · JKC
Nichols Institute
Chemistry · 105d
Cleared May 15, 1995
ACE AMYLASE REAGENT
K951548 · JFJ
Schiapparelli Biosystems, Inc.
Chemistry · 41d
Cleared May 15, 1995
T-UPTAKE EIA TEST
K951586 · KHQ
Diagnostic Reagents, Inc.
Chemistry · 39d
Cleared May 15, 1995
COAT-A-COUNT LH IRMA
K951748 · CEP
Diagnostic Products Corp.
Chemistry · 28d
Cleared May 15, 1995
BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3
K951749 · JJY
Biocell Laboratories, Inc.
Chemistry · 28d
Cleared May 15, 1995
HICHEM ALT REAGENT KIT
K951818 · CKA
Hi Chem, Inc.
Chemistry · 25d