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
9457–9480 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 29, 1985
SUGAR-CHEX
K851042 · JJX
Streck Laboratories, Inc.
Chemistry · 46d
Cleared Apr 29, 1985
SUGAR-CHEX II
K851043 · JJX
Streck Laboratories, Inc.
Chemistry · 46d
Cleared Apr 29, 1985
TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE
K851148 · JLW
Euro-Diagnostics BV
Chemistry · 39d
Cleared Apr 29, 1985
GEMENI AST-LTS REAGENTS
K851267 · CIT
Electro-Nucleonics Laboratories, Inc.
Chemistry · 31d
Cleared Apr 29, 1985
PROLACTIN SYSTEM BY RIA
K851330 · CFT
American Bioclinical, Inc.
Chemistry · 25d
Cleared Apr 29, 1985
ION 2 REAGENT KI
K851350 · CEM
Hi Chem, Inc.
Chemistry · 25d
Cleared Apr 25, 1985
BEHRING VECTOR PHOTOMETER
K851098 · JJQ
Behring Diagnostics, Inc.
Chemistry · 37d
Cleared Apr 25, 1985
ACTIVE DHEA-SULFATE DSL3500
K851239 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 29d
Cleared Apr 25, 1985
ATAC 2000 CHEMISTRY ANALYZER
K851321 · JQP
Turpen Laboratory Systems, Inc.
Chemistry · 23d
Cleared Apr 17, 1985
ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS
K850360 · CHL
Text Tech Corp.
Chemistry · 77d
Cleared Apr 17, 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · CIX
Technicon Instruments Corp.
Chemistry · 16d
Cleared Apr 12, 1985
INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS
K850392 · JJQ
Clinical Data, Inc.
Chemistry · 70d
Cleared Apr 12, 1985
MEDIX VISUAL URINE HCG (7/7) TEST
K850949 · JHI
Medix Biotech, Inc.
Chemistry · 36d
Cleared Apr 12, 1985
PHARMACIA INSULIN RIA
K851071 · CFP
Pharmacia, Inc.
Chemistry · 25d
Cleared Apr 10, 1985
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H
K850575 · JJY
American Dade
Chemistry · 56d
Cleared Apr 10, 1985
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079 · JJX
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Apr 10, 1985
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104 · CEP
Amersham Corp.
Chemistry · 22d
Cleared Apr 08, 1985
BACI 6 -ADRENOCORTICOTROOP HORMONE
K850053 · CKG
Euro-Diagnostics BV
Chemistry · 90d
Cleared Apr 08, 1985
PRECO PREGNANCY RAPID CARD TEST, HEM #2028
K850604 · JHJ
Preco, Inc.
Chemistry · 52d
Cleared Apr 08, 1985
DATA ZYME CO2 PROCEDURE
K850903 · KHS
Data Medical Associates, Inc.
Chemistry · 34d
Cleared Apr 08, 1985
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
K850987 · JHI
Medix Biotech, Inc.
Chemistry · 28d
Cleared Apr 08, 1985
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
K850999 · JJF
Technicon Instruments Corp.
Chemistry · 28d
Cleared Apr 03, 1985
ABBOTT TDT EIA
K843908 · CIG
Abbott Laboratories
Chemistry · 182d
Cleared Apr 03, 1985
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
K850254 · CEW
Cambridge Medical Technology
Chemistry · 71d