Medical Device Manufacturer · US , Sterling Heights , MI

Sterling Diagnostics, Inc.

41 submissions · 41 cleared · Since 1985
41
Total
41
Cleared
0
Denied

Sterling Diagnostics, Inc. — FDA 510(k) Submissions

Sterling Diagnostics, Inc. has submitted 41 FDA 510(k) premarket notifications since 1985, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Biuret (colorimetric), Total Protein, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides, Photometric Method, Iron (non-heme), Nadh Oxidation/nad Reduction, Alt/sgpt, Enzymatic Esterase--oxidase, Cholesterol . Use the specialty filter in the sidebar to narrow results.

41 devices
1–12 of 41
MICROPROTEIN REAGENT SET
K921412 · CEK Biuret (colorimetric),... · Chemistry
Jan 1993 303d
TRIGLYCERIDES REAGENT SET
K914609 · CDT Lipase... · Chemistry
Nov 1991 21d
SODIUM REAGENT SET
K914039 · CEI Uranyl Acetate/zinc... · Chemistry
Oct 1991 51d
PHOSPHOLIPID REAGENT SET
K914040 · JNT Chromatographic,... · Chemistry
Oct 1991 50d
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255 · CFJ Nad Reduction/nadh... · Chemistry
Jul 1986 46d
VANILMANDELIC ACID (VMA) REAGENT SET
K861962 · CDF Acid, Vanilmandelic,... · Chemistry
Jul 1986 48d
UREA NITROGEN (GLDH) REAGENT SET (UV)
K862210 · CDQ Urease And Glutamic... · Chemistry
Jul 1986 21d
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
K862256 · CJE Nitrophenylphosphate,... · Chemistry
Jul 1986 18d
ALT (SGPT) REAGENT SET (UV RATE)
K862209 · CKA Nadh Oxidation/nad... · Chemistry
Jun 1986 15d
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
K861855 · JKF Dinitrophenyl Hydrazone... · Chemistry
Jun 1986 33d
SALICYLATE REAGENT SET
K861615 · DKJ Colorimetry, Salicylate · Toxicology
May 1986 24d
SERUM POTASSIUM REAGENT SET
K861713 · CEJ Tetraphenyl Borate,... · Chemistry
May 1986 18d

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