ULTRAZYME-GT, ITEM #64959 & 65032— 510(k) K813041

Substantially Equivalent

Harleco

FDA 510(k) clearance K813041 for ULTRAZYME-GT, ITEM #64959 & 65032, Substantially Equivalent on 1981-11-10. 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: 1981-10-28
Decision date: 1981-11-10
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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K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES1997-01-13
K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE1997-01-10

More clearances from Harleco

K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056)1982-02-12
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

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