FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12145–12168 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 13, 1979
THYROID STIMULATING HORMONE
K792154 · JLW
Radioimmunoassay, Inc.
Chemistry · 19d
Cleared Nov 13, 1979
125 I PROLACTIN HORMONE RIA KIT
K792166 · CFT
Diagnostic Products Corp.
Chemistry · 15d
Cleared Nov 13, 1979
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · CGN
Abbott Laboratories
Chemistry · 18d
Cleared Nov 13, 1979
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · CDD
New England Nuclear
Chemistry · 15d
Cleared Nov 13, 1979
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180 · JJS
Corning Medical & Scientific
Chemistry · 15d
Cleared Nov 13, 1979
DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
K792183 · LBS
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 15d
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