UNIPAK GLUCOSE— 510(k) K771091

Substantially Equivalent

Harleco

FDA 510(k) clearance K771091 for UNIPAK GLUCOSE, Substantially Equivalent on 1977-07-21. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code CGE
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1977-06-16
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code CGE

K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.1989-02-17
K855185 — GLUCOSE REAGENT SET1986-01-22
K850930 — GLUCOSE1985-06-10
K841054 — DIRECT GLUCOSE REAGENT SET1984-05-01
K821198 — DIRECT GLUCOSE REAGENT SET1982-07-13

More clearances from Harleco

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K813038 — ULTRACHEM TP, ITEM #649741981-11-10
K813039 — ULTRACHEM E-CHOL, ITEM #650251981-11-10
K813040 — ULTRACHEM CA, ITEM #649751981-11-10

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