FASTEC 901 AGGLUTINATION PATTERN READER— 510(k) K895967

Name: FDA 510(k) clearance K895967
Creator: U.S. Food and Drug Administration
Published: 1989-10-30

Substantially Equivalent

Schiff & Co.

FDA 510(k) clearance K895967 for FASTEC 901 AGGLUTINATION PATTERN READER, Substantially Equivalent on 1989-10-30. Applicant: Schiff & Co.. Device class: 1.

Clearance details

Applicant: Schiff & Co.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1989-10-12
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Download summary PDF View on FDA.gov ↗

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