GLUCOSE REAGENT SET— 510(k) K855185

Substantially Equivalent

Technostics Intl.

FDA 510(k) clearance K855185 for GLUCOSE REAGENT SET, Substantially Equivalent on 1986-01-22. Applicant: Technostics Intl.. Device class: 2.

Clearance details

Applicant: Technostics Intl.
Product code: Code CGE
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1985-12-26
Decision date: 1986-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, MI, US

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Recent devices under product code CGE

K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.1989-02-17
K850930 — GLUCOSE1985-06-10
K841054 — DIRECT GLUCOSE REAGENT SET1984-05-01
K821198 — DIRECT GLUCOSE REAGENT SET1982-07-13
K811883 — KING DIAGNOSTICS GLUCOSE-O TEST1981-07-23

More clearances from Technostics Intl.

K855188 — CPK (UV) REAGENT KIT1986-03-05
K860111 — URIC ACID REAGENT SET1986-02-19
K855190 — MAGNESIUM REAGENT SET1986-02-18
K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET1986-02-11
K860109 — ENZYMATIC UREA NITROGEN REAGENT SET1986-02-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.