ANA/LITE-HEP-2 TEST SYSTEM— 510(k) K852231

Name: FDA 510(k) clearance K852231
Creator: U.S. Food and Drug Administration
Published: 1985-07-10

Substantially Equivalent

Immuno-Products Industries

FDA 510(k) clearance K852231 for ANA/LITE-HEP-2 TEST SYSTEM, Substantially Equivalent on 1985-07-10. Applicant: Immuno-Products Industries. Device class: 2.

Clearance details

Applicant: Immuno-Products Industries
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1985-05-22
Decision date: 1985-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: So. Bound Brook, NJ, US

Download summary PDF View on FDA.gov ↗

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