Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

46 results for "Biotrol, USA, Inc."
25–46 of 46
Search insights Median review: 43d Cleared: 100% Top manufacturer: Biotrol, USA, Inc. Lead specialty: Chemistry
Cleared May 16, 1988
BIOTROL CK MONOEACTIF
K881267 · JHX
Biotrol, USA, Inc.
Chemistry · 53d
Cleared Apr 28, 1988
BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K881311 · JQB
Biotrol, USA, Inc.
Chemistry · 31d
Cleared Apr 12, 1988
BIOTROL TOXO ELISA TEST G
K873294 · LGD
Biotrol, USA, Inc.
Microbiology · 239d
Cleared Apr 12, 1988
BIOTROL TOXO ELISA TEST M
K873293 · LGD
Biotrol, USA, Inc.
Microbiology · 239d
Cleared Feb 03, 1988
BIOTROL CALIBRANT LEVEL 2
K875304 · JIX
Biotrol, USA, Inc.
Chemistry · 36d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 3
K875318 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 1
K875288 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 01, 1988
BIOTROL URIC ACID ENZYMATIQUE UV H.P.
K875320 · CDO
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Jan 07, 1988
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
K874809 · JJY
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Jan 05, 1988
BIOTROL BICARBONATE (CO2) UV HP)
K874941 · KHS
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Jan 05, 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Sep 08, 1987
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
K873160 · CDT
Biotrol, USA, Inc.
Chemistry · 28d
Cleared Sep 04, 1987
BIOTROL ALPHA AMYLASE
K872831 · CIJ
Biotrol, USA, Inc.
Chemistry · 49d
Cleared Sep 02, 1987
BIOTROL MAGNESIUM CALMAGITE
K873180 · JGJ
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Sep 02, 1987
BIOTROL REFERENCE
K873118 · JIX
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Sep 02, 1987
MULTI ANALYTE MIXTURES, CALIBRATORS
K873116 · JIX
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Aug 31, 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · CGA
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Aug 26, 1987
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
K872785 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 26, 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 21, 1987
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · CHH
Biotrol, USA, Inc.
Chemistry · 25d
Cleared Aug 13, 1987
BIOTROL ALT/TGP MONOREACTIF
K872830 · CKA
Biotrol, USA, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
BIOTROL AST/TGO MONOREACTIF
K872829 · CIT
Biotrol, USA, Inc.
Chemistry · 27d