ULTRA ZYME PLUS CK-1 #64978, 65027 & 28— 510(k) K812593

Name: FDA 510(k) clearance K812593
Creator: U.S. Food and Drug Administration
Published: 1981-10-02

Substantially Equivalent

Harleco

FDA 510(k) clearance K812593 for ULTRA ZYME PLUS CK-1 #64978, 65027 & 28, Substantially Equivalent on 1981-10-02. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1981-09-11
Decision date: 1981-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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

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