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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11185–11208 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 31, 1981
UREA NITROGEN REAGENT SET
K813415 · CDW
Anco Medical Reagents & Assoc.
Chemistry · 24d
Cleared Dec 31, 1981
ULTRACHEM GLUC-DH
K813427 · LFR
Harleco
Chemistry · 24d
Cleared Dec 31, 1981
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR
K813447 · JIS
Rna Medical Corp.
Chemistry · 30d
Cleared Dec 31, 1981
PHE/TYR KINETIC UV TEST SET
K813449 · JNB
P-L Biochemicals, Inc.
Chemistry · 21d
Cleared Dec 31, 1981
FREE T4 RIA TEST SET
K813465 · CEC
Ventrex Laboratories, Inc.
Chemistry · 20d
Cleared Dec 31, 1981
LIPID PROFILE
K813469 · CFD
Bio-Analytics Laboratories, Inc.
Chemistry · 20d
Cleared Dec 31, 1981
ALT (SGPT)
K813495 · CKA
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Dec 31, 1981
LDH-L
K813496 · CFJ
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Dec 31, 1981
FLAME PHOTOMETER CALIBRATION STANDARDS
K813505 · JIS
Fisher Scientific Co., LLC
Chemistry · 16d
Cleared Dec 31, 1981
URIC-ACID
K813511 · KNK
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Dec 31, 1981
BLOOD GAS ANALYSIS, STANDARDS CONTROLS
K813517 · CHL
United Diagnostics, Inc.
Chemistry · 15d
Cleared Dec 31, 1981
CENTIDISC
K813524 · JQC
Bel-Art Products
Chemistry · 15d
Cleared Dec 31, 1981
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY
K813525 · JLW
Micromedic Systems
Chemistry · 15d
Cleared Dec 31, 1981
DADE COLORIMETRIC AMYLASE
K813529 · CIJ
American Dade
Chemistry · 14d
Cleared Dec 31, 1981
ASTRA TOTAL PROTEIN REAGENT
K813536 · CEK
Hi Chem, Inc.
Chemistry · 13d
Cleared Dec 31, 1981
A FLUOROMETER
K813540 · KHO
American Diagnostic Corp.
Chemistry · 10d
Cleared Dec 30, 1981
125I FERRITIN RADIOIMMUNOASSAY KIT
K812901 · DBF
Bio-Ria
Chemistry · 75d
Cleared Dec 22, 1981
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
K813213 · CEP
Intl. Immunoassay Laboratories, Inc.
Chemistry · 43d
Cleared Dec 22, 1981
AMMONIA TEST
K813366 · JID
Wako Pure Chemical Industries, Ltd.
Chemistry · 22d
Cleared Dec 22, 1981
ELECTROLYTE GEL
K813370 · CGA
Hi Chem, Inc.
Chemistry · 22d
Cleared Dec 22, 1981
RADIOIMMUNOASSAY FOR HUMAN THYROID
K813392 · JLW
Leeco Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 22, 1981
COAT-A-COUNT TESTOSTERONE RIA KIT
K813401 · CDZ
Diagnostic Products Corp.
Chemistry · 18d
Cleared Dec 22, 1981
AST(SGOT) IN VITRO DIAG. REAGENT SET
K813405 · CIT
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Dec 22, 1981
CPK(CK) IN VITRO DIAG. REAGENT SET
K813406 · JHS
Pointe Scientific, Inc.,
Chemistry · 15d