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
12169–12192 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 13, 1979
NORDICLAB TOTAL ESTRIOL RIA TEST
K792189 · CGI
Nordiclab Intl.
Chemistry · 13d
Cleared Nov 13, 1979
8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
K792196 · JJR
Photovolt Corp.
Chemistry · 12d
Cleared Nov 05, 1979
PROTEIN ASSAY KIT
K790808 · CEK
Specialty Medical Industries, Inc.
Chemistry · 193d
Cleared Nov 05, 1979
RIA KIT FOR TRYPSIN
K791202 · JNO
Cis Radiopharmaceuticals, Inc.
Chemistry · 130d
Cleared Nov 05, 1979
WORTHINGTON TRIGLYCERIDES REAGENT SET
K791962 · JGY
Worthington Diagnostic Systems
Chemistry · 35d
Cleared Oct 30, 1979
OREIA-TU THYROID UPTAKER RATIO ASSAY
K791172
Organon, Inc.
Chemistry · 127d
Cleared Oct 30, 1979
VMA BY COLUMN TEST
K791837 · CDF
Bio-Rad
Chemistry · 46d
Cleared Oct 30, 1979
(125I) TESTOSTERONE KIT
K791999 · CDZ
Radioassay Systems Laboratories, Inc.
Chemistry · 25d
Cleared Oct 30, 1979
LUTEINIZING HORMONE (LH) RIA
K792000 · CEP
Cis Radiopharmaceuticals, Inc.
Chemistry · 25d
Cleared Oct 30, 1979
ESKACHEM, CK-MB REAGENT
K792023 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 21d
Cleared Oct 30, 1979
LIPOTROL
K792024 · JJY
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
K792025 · JJY
Helena Laboratories
Chemistry · 21d
Cleared Oct 30, 1979
CORTISOL RADIOIMMUNOASSAY SYSTEM
K792036 · CGR
Radioimmunoassay, Inc.
Chemistry · 19d
Cleared Oct 30, 1979
DHEA-SULFATE TEST SET
K792041 · JKC
Wien Laboratories, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
PAP-CHECK RIA KIT
K792043 · JFH
Serono Laboratories, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
BIOVATION NEPHELOMETER
K792045 · JQX
Biovation, Inc.
Chemistry · 18d
Cleared Oct 30, 1979
URIC ACID STANDARD
K792046 · JIS
Gilford Diagnostics
Chemistry · 18d
Cleared Oct 26, 1979
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373 · CFE
Hoffmann-La Roche, Inc.
Chemistry · 94d
Cleared Oct 17, 1979
BE-SURE
K791706 · JHJ
Precision Products Corp.
Chemistry · 61d
Cleared Oct 17, 1979
CENTRIA INSULIN RIA
K791707 · CFP
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Oct 17, 1979
CENTRIA TSH RIA
K791855 · JLW
Union Carbide Corp.
Chemistry · 28d
Cleared Oct 17, 1979
CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD
K791874 · JIX
Gilford Diagnostics
Chemistry · 26d
Cleared Oct 17, 1979
SERACON - EL DO27
K791958 · JJY
Bhp Diagnostix, Inc.
Chemistry · 16d
Cleared Oct 17, 1979
EIA (ELISA) READER
K791968 · JJQ
Gilford Instrument Laboratories, Inc.
Chemistry · 16d