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
9601–9624 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 03, 1985
CREATININE REAGENT FOR DEMAND ANALYZER
K844332 · CGX
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
GEMCAL ENI REFERENCE SERUM
K844344 · JIX
Biocell Laboratories, Inc.
Chemistry · 55d
Cleared Dec 18, 1984
UROPAPER EIKEN GP
K843753 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 7
K843754 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 6B
K843755 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 5
K843756 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN AG
K843757 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN GK
K843758 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN HAG
K843759 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN G
K843760 · JIL
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 14, 1984
CONCEP-7-BHCG (EIA)
K844153 · JHI
Leeco Diagnostics, Inc.
Chemistry · 51d
Cleared Dec 12, 1984
UROPAPER EIKEN 8
K843532 · KHE
Syn-Kit, Inc.
Chemistry · 96d
Cleared Dec 12, 1984
80 MG/DL GLUCOSE CONTROL
K844581 · JIS
Boehringer Mannheim Corp.
Chemistry · 19d
Cleared Dec 12, 1984
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
K844720 · JQB
Data Medical Associates, Inc.
Chemistry · 8d
Cleared Dec 11, 1984
OVUSTICK SELF-TEST
K843284 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 113d
Cleared Dec 11, 1984
CORNING 614 NA/K ANALYZER
K843530 · JGS
Corning Medical & Scientific
Chemistry · 95d
Cleared Dec 11, 1984
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408 · CGI
Amersham Corp.
Chemistry · 27d
Cleared Dec 11, 1984
TRIGLYCERIDE CALIBRATOR
K844468 · JIT
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Dec 11, 1984
REFERRIL CALIBRATORS
K844585 · JIX
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Dec 11, 1984
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
K844586 · JJF
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Dec 10, 1984
ISE REAGENTS FOR DEMAND ANALYZER
K844021 · CGZ
Advanced Biomedical Methods, Inc.
Chemistry · 56d
Cleared Dec 10, 1984
REACTIFS, IBF ULTROGELS ACA & ULTROGELS A
K844164 · DII
Lkb Instruments, Inc.
Chemistry · 46d
Cleared Dec 10, 1984
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
K844171 · LGR
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Dec 10, 1984
PTK HEALTHCHECK PREGNANCY TEST KIT
K844281 · LCX
Healthcheck Corp.
Chemistry · 35d