IMMUCHEM COVALENT COAT SOLID PHASE ASSAY— 510(k) K791664

Name: FDA 510(k) clearance K791664
Creator: U.S. Food and Drug Administration
Published: 1979-09-27

Substantially Equivalent

Immuchem Corp.

FDA 510(k) clearance K791664 for IMMUCHEM COVALENT COAT SOLID PHASE ASSAY, Substantially Equivalent on 1979-09-27. Applicant: Immuchem Corp.. Device class: 2.

Clearance details

Applicant: Immuchem Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1979-08-21
Decision date: 1979-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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