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
12145–12168 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 06, 1979
ELVI CALCIUM
K792396 · CIA
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI ALBUMIN
K792408 · CIX
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI TOTAL IRON BINDING CAPACITY
K792409 · JQF
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI SGOT & SGPT TRANSAMINASE
K792410 · CIS
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792411 · CIG
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 04, 1979
PROSTATIC ACID RADIOIMMUNOASSAY TEST
K791497 · JFH
Clinical Assays, Inc.
Chemistry · 123d
Cleared Nov 27, 1979
HARLECO BRAND CLINICARD LIPASE TEST SET
K791922 · CET
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 62d
Cleared Nov 27, 1979
DURAZYME GOT/AST
K792208 · CIT
American Monitor Corp.
Chemistry · 25d
Cleared Nov 27, 1979
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES
K792234 · CDT
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Nov 15, 1979
CARDIO CK-B RIA KIT
K791582 · JHX
Nuclear Medical Systems, Inc.
Chemistry · 92d
Cleared Nov 15, 1979
PAP RIA KIT
K791735 · JFH
Nuclear Medical Systems, Inc.
Chemistry · 77d
Cleared Nov 13, 1979
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216 · CDD
Ventrex Laboratories, Inc.
Chemistry · 134d
Cleared Nov 13, 1979
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · JLW
Abbott Laboratories
Chemistry · 64d
Cleared Nov 13, 1979
CORNING GLYCOSYLATED HEMOGLOBIN SET
K791777 · LCP
Corning Medical & Scientific
Chemistry · 64d
Cleared Nov 13, 1979
MICROFLAME PHOTOMETER
K792087 · JJO
Gilford Instrument Laboratories, Inc.
Chemistry · 27d
Cleared Nov 13, 1979
GAS-TRAK BLOOD GAS CONTROL
K792098 · JJS
United Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 13, 1979
SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
K792138 · CEK
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Nov 13, 1979
FISHER DIAG. PRIME BLOOD GAS CONTROLS
K792143 · JJS
Fisher Scientific Co., LLC
Chemistry · 20d
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