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
12601–12624 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 06, 1978
CENTRIA CORTISOL RIA
K780725 · CGR
Union Carbide Corp.
Chemistry · 34d
Cleared Jun 06, 1978
KRYORACK/4
K780757 · JRR
Streck Laboratories, Inc.
Chemistry · 29d
Cleared Jun 06, 1978
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
K780783 · CHH
J.T. Baker Chemical Co.
Chemistry · 25d
Cleared Jun 06, 1978
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 25d
Cleared May 26, 1978
DYNEX BLOOD GAS QUALITY CONTROL SYS.
K780144 · JJS
Analytical Products, Inc.
Chemistry · 122d
Cleared May 26, 1978
TOTAL IRON BINDING CAPACITY
K780412 · JQG
Diagnostic Corp. of America
Chemistry · 72d
Cleared May 26, 1978
THERMAJUST CIRCU-TEMP
K780543 · JRQ
Techhnilab Instruments, Inc.
Chemistry · 53d
Cleared May 26, 1978
SR-PLUS DIRECT CHOLESTEROL TEST
K780545 · CGO
Stanbio Laboratory
Chemistry · 53d
Cleared May 26, 1978
ACCESSORY HDL CHOLESTEROL REAGENT SET
K780638 · CHH
The Dow Chemical Co.
Chemistry · 38d
Cleared May 26, 1978
FLAME PHOTOMETER, MODEL 435
K780649 · JJO
Corning Medical & Scientific
Chemistry · 37d
Cleared May 26, 1978
FLAME PHOTOMETER, MODEL 455
K780650 · JJO
Corning Medical & Scientific
Chemistry · 37d
Cleared May 26, 1978
TRIGLYCERIDE C-37 RAPID STAT KIT
K780825 · JGY
Pierce Chemical Co.
Chemistry · 7d
Cleared May 26, 1978
BILIRUBIN RAPID STAT KIT
K780826 · CIG
Pierce Chemical Co.
Chemistry · 7d
Cleared May 19, 1978
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
K780513 · CIJ
Harleco
Chemistry · 50d
Cleared May 19, 1978
ULTRACHEM CREATININE 64972, CENTRIFUCHEM
K780514 · CGX
Harleco
Chemistry · 50d
Cleared May 19, 1978
ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM
K780515 · CFR
Harleco
Chemistry · 50d
Cleared May 19, 1978
ULTRACHEM ENZYMATIC CHOLESTEROL 65025
K780523 · CHH
Harleco
Chemistry · 49d
Cleared May 19, 1978
ULTRACHEM T-BILI 64971 GILFORD 3500
K780524 · CIG
Harleco
Chemistry · 49d
Cleared May 19, 1978
T-3 UPTAKE (SORBENT) KIT
K780525 · KHQ
Amersham Corp.
Chemistry · 49d
Cleared May 19, 1978
UREA NITROGEN (ENZYMATIC)
K780534 · CDQ
Macomb Chemical Co.
Chemistry · 46d
Cleared May 19, 1978
ALFATEST
K780542 · LBR
Panmed, Inc.
Chemistry · 46d
Cleared May 19, 1978
COMP. CLIN. CHEM. CONTROL SERUM-DECISION
K780552 · JJY
Beckman Instruments, Inc.
Chemistry · 44d
Cleared May 19, 1978
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK
K780553 · JIX
Beckman Instruments, Inc.
Chemistry · 44d
Cleared May 19, 1978
125-I LABELED HUMAN LUTEINIZING HORMONE
K780576 · CEP
Pcl-Ria, Inc.
Chemistry · 39d