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
13201–13224 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 26, 1976
ULTRAZYME HBD
K760023 · JMK
Harleco
Chemistry · 73d
Cleared Aug 26, 1976
ULTRAZYME ALKALINE PHOSPHATASE
K760024 · CJE
Harleco
Chemistry · 73d
Cleared Aug 26, 1976
ULTRAZYME GT
K760025 · JPZ
Harleco
Chemistry · 73d
Cleared Aug 26, 1976
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER
K760055 · CFR
Smithkline Diagnostics, Inc.
Chemistry · 71d
Cleared Aug 26, 1976
ANALYZER, GLUCOSE/UREA/CREATININE
K760211 · JJC
Instrumentation Laboratory CO
Chemistry · 45d
Cleared Aug 26, 1976
ACID BASE SYSTEM, RADIOMETER AUTOMATED
K760229 · CHL
The London Co.
Chemistry · 43d
Cleared Aug 26, 1976
PRINTER, IL 460
K760232 · JJQ
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Aug 26, 1976
TABLE, SAMPLE IL 461
K760233 · JJQ
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Aug 26, 1976
GLUCOSE REAGENT SYS, SIGMA PROCED. 115
K760247 · CFR
Sigma Chemical Co.
Chemistry · 38d
Cleared Aug 26, 1976
REAGENT, P-NITROPHENYL PHOSPHATE
K760399 · CJE
J.T. Baker Chemical Co.
Chemistry · 20d
Cleared Aug 23, 1976
SIGMA AMMONIA REAGENT
K760332 · JIF
Sigma Chemical Co.
Chemistry · 26d
Cleared Aug 11, 1976
PROBECOT II
K760242
Measurement-Science Corp.
Chemistry · 27d
Cleared Aug 11, 1976
TEST SYSTEM, RIA CORTISOL
K760256 · CGR
Corning Medical & Scientific
Chemistry · 23d
Cleared Aug 03, 1976
NDC#12739-0011-1 C-ZYME GOT
K760193 · CIT
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
NDC#12739-0010-1 C-ZYME GPT
K760194 · CKA
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
K760195 · CDT
Coulter Electronics, Inc.
Chemistry · 28d
Cleared Aug 03, 1976
RADIOASSY KIT, 3H-FOLATE
K760262 · CGN
Diamond Shamrock Corp.
Chemistry · 13d
Cleared Jul 26, 1976
COLORIMETRIC DETERMINATION (SGOT/SGPT)
K760010 · CIT
The Dow Chemical Co.
Chemistry · 46d
Cleared Jul 26, 1976
REAGENT, TRIGLYCERIDES
K760011 · CDT
The Dow Chemical Co.
Chemistry · 46d
Cleared Jul 26, 1976
KIT, RIA, HUMAN THYROID HORMONE
K760044 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 41d
Cleared Jul 26, 1976
KIT, FOLATE RADIOASSAY SC.7
K760207 · CGN
Amersham Corp.
Chemistry · 17d
Cleared Jul 20, 1976
RADIOASSAY, CONCEPT 4
K760006
Micromedic Systems
Chemistry · 43d
Cleared Jul 20, 1976
COLORIMETRIC DETERMINATION (LDH)
K760009 · CFH
The Dow Chemical Co.
Chemistry · 40d
Cleared Jul 20, 1976
KIT, RADIOASSAY, SERUM IRON
K760045 · JJA
Bd Becton Dickinson Vacutainer...
Chemistry · 35d