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
12697–12720 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 03, 1978
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY
K780219 · CDX
Syva Co.
Chemistry · 21d
Cleared Feb 28, 1978
FLAME PHOTOMETER STANDARD
K772153 · JIT
Alko Scientific Co.
Chemistry · 105d
Cleared Feb 27, 1978
PREDICTOR
K780240 · LCX
Organon, Inc.
Chemistry · 14d
Cleared Feb 23, 1978
ISOENZYME SERUM CONTROL
K780147 · JJT
Corning Medical & Scientific
Chemistry · 24d
Cleared Feb 23, 1978
SPECTROPHOTOMETER, MODEL 380
K780156 · JJQ
Turner Assoc.
Chemistry · 24d
Cleared Feb 14, 1978
BUN REAGNET SET
K780069 · CDQ
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Feb 14, 1978
GAMA-GPT REAGENT SET
K780071 · JQB
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Feb 14, 1978
GLUCOSE REAGENT SET
K780072 · CFR
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Feb 14, 1978
ULTRAZYME PLUS LDH
K780101 · CFJ
Harleco
Chemistry · 25d
Cleared Feb 13, 1978
THYROXINE STDS. IN HUMAN SERUM
K780050 · CDX
Pcl-Ria, Inc.
Chemistry · 35d
Cleared Feb 13, 1978
RABBIT ANTIBODY/THYROID STIMUL. HORMONE
K780059 · JLW
Pcl-Ria, Inc.
Chemistry · 34d
Cleared Feb 13, 1978
CPK REAGENT SET
K780070 · CGS
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
HBDH REAGENT SET
K780073 · JMK
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
LDH-L REAGENT SET
K780074
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
GLUCOSE REAGENT FOR GLUCOSE ANALYZER
K780093 · CGA
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
IRON BINDING CAPACITY CHEMISTRY
K780094 · JMO
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
ULTRAZYME PLUS ALP
K780095 · CJE
Harleco
Chemistry · 26d
Cleared Feb 13, 1978
ULTRAZYME PLUS GPT
K780102 · CKA
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
ULTRAZYME PLUS GOT
K780103 · CIT
Harleco
Chemistry · 24d
Cleared Feb 13, 1978
ULTRAZYME PLUS HBD
K780104 · JMK
Harleco
Chemistry · 24d
Cleared Feb 07, 1978
ALP REAGENT SET
K780068 · CJE
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Feb 07, 1978
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080 · CFE
Corning Medical & Scientific
Chemistry · 22d
Cleared Feb 07, 1978
ULTRACHEM ALBUMIN
K780092 · CIX
Harleco
Chemistry · 20d
Cleared Feb 01, 1978
LACTATE DEHYDROGENASE
K780041 · CFJ
Beckman Instruments, Inc.
Chemistry · 23d