Medical Device Manufacturer · US , Washington , MI

Technostics Intl.

21 submissions · 21 cleared · Since 1986
21
Total
21
Cleared
0
Denied

Technostics Intl. — FDA 510(k) Submissions

Technostics Intl. has submitted 21 FDA 510(k) premarket notifications since 1986, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nad Reduction/nadh Oxidation, Lactate Dehydrogenase, Colorimetric Method, Gamma-glutamyl Transpeptidase, Diazo Colorimetry, Bilirubin, Bromcresol Green Dye-binding, Albumin, Urease And Glutamic Dehydrogenase, Urea Nitrogen . Use the specialty filter in the sidebar to narrow results.

21 devices
1–12 of 21
CPK (UV) REAGENT KIT
K855188 · JHS Differential Rate Kinetic... · Chemistry
Mar 1986 69d
URIC ACID REAGENT SET
K860111 · LFQ Acid, Uric, Acid... · Chemistry
Feb 1986 37d
MAGNESIUM REAGENT SET
K855190 · JGJ Photometric Method,... · Chemistry
Feb 1986 54d
GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET
K860110 · CKA Nadh Oxidation/nad... · Chemistry
Feb 1986 29d
ENZYMATIC UREA NITROGEN REAGENT SET
K860109 · CDQ Urease And Glutamic... · Chemistry
Feb 1986 24d
TOTAL LIPIDS REAGENT SET
K860112 · CFD Sulfophosphovanillin,... · Chemistry
Jan 1986 11d
GLUCOSE REAGENT SET
K855185 · CGE Orthotoluidine, Glucose · Chemistry
Jan 1986 27d
LACTIC DEHYDROGENASE (VV) REAGENT SET
K855157 · CFJ Nad Reduction/nadh... · Chemistry
Jan 1986 26d
GLUCOSE (UV HEXOKIASE) REAGENT SET
K855153 · CFR Hexokinase, Glucose · Chemistry
Jan 1986 19d
INORGANIC PHOSPHORUS REAGENT SET
K855154 · CEO Phosphomolybdate... · Chemistry
Jan 1986 19d
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET
K855156 · JPZ Colorimetric Method,... · Chemistry
Jan 1986 19d
ALBUMIN REAGENT SET
K855158 · CIX Bromcresol Green... · Chemistry
Jan 1986 19d
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