ULTRAZYME PLUS GAMMA GT(65055-65056)— 510(k) K820233

Substantially Equivalent

Harleco

FDA 510(k) clearance K820233 for ULTRAZYME PLUS GAMMA GT(65055-65056), Substantially Equivalent on 1982-02-12. Applicant: Harleco. Device class: 1.

Clearance details

Applicant: Harleco
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1982-01-28
Decision date: 1982-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JQB

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K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)1997-05-06
K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES1997-01-13
K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE1997-01-10

More clearances from Harleco

K813427 — ULTRACHEM GLUC-DH1981-12-31
K813038 — ULTRACHEM TP, ITEM #649741981-11-10
K813039 — ULTRACHEM E-CHOL, ITEM #650251981-11-10
K813040 — ULTRACHEM CA, ITEM #649751981-11-10
K813041 — ULTRAZYME-GT, ITEM #64959 & 650321981-11-10

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