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
12625–12648 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared May 19, 1978
REAGENT SET HDL CHOLESTEROL
K780635 · CHH
Boehringer Mannheim Corp.
Chemistry · 32d
Cleared May 18, 1978
SINGLE VIAL 10 SGPT-TRIS
K780636 · CKA
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared May 12, 1978
DATA-ZYME TRIGLYCERIDE PROCEDURE
K780379 · CDT
Data Medical Associates, Inc.
Chemistry · 65d
Cleared May 12, 1978
ALT(GPT) UNI-UV, SGPT
K780462 · CKA
Sclavo, Inc.
Chemistry · 50d
Cleared May 12, 1978
AST(GOT) UNI-UV, SGOT
K780463 · CIT
Sclavo, Inc.
Chemistry · 50d
Cleared May 04, 1978
CBR-T3RIA KIT
K780499 · CDP
Clinical Bioresearch
Chemistry · 37d