Medical Device Manufacturer · US , Santa Fe Springs , CA

Derma Media Lab., Inc.

18 submissions · 18 cleared · Since 1996
18
Total
18
Cleared
0
Denied

Derma Media Lab., Inc. — FDA 510(k) Submissions

Derma Media Lab., Inc. has submitted 18 FDA 510(k) premarket notifications since 1996, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Photometric Method, Magnesium, Kinetic Method, Gamma-glutamyl Transpeptidase, Bromcresol Green Dye-binding, Albumin, Nadh Oxidation/nad Reduction, Ast/sgot, Biuret (colorimetric), Total Protein . Use the specialty filter in the sidebar to narrow results.

18 devices
1–12 of 18
GLUCOSE REAGENT
K970664 · CFR Hexokinase, Glucose · Chemistry
Aug 1997 161d
UREA
K971309 · CDQ Urease And Glutamic... · Chemistry
Aug 1997 115d
CHOLESTEROL REAGENT
K971072 · CHH Enzymatic... · Chemistry
Jun 1997 88d
URIC ACID REAGENT
K970867 · KNK Acid, Uric, Uricase... · Chemistry
Apr 1997 42d
TRIGLYCERIDES
K971005 · JGY Colorimetric Method,... · Chemistry
Apr 1997 33d
MAGNESIUM
K964915 · JGJ Photometric Method,... · Chemistry
Mar 1997 107d
IRON REAGENT
K964913 · JIY Photometric Method, Iron... · Chemistry
Feb 1997 73d
ALT/SGPT
K965134 · CKA Nadh Oxidation/nad... · Chemistry
Feb 1997 57d
ALKALINE PHOSPHATASE
K964914 · CJE Nitrophenylphosphate,... · Chemistry
Feb 1997 57d
AST/SGOT
K965126 · CIT Nadh Oxidation/nad... · Chemistry
Jan 1997 25d
GAMMA-GLUTAMYL TRANSPEPTIDASE
K964916 · JQB Kinetic Method,... · Chemistry
Jan 1997 32d
LACTATE DEHYDROGENASE
K964912 · CFJ Nad Reduction/nadh... · Chemistry
Jan 1997 31d
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