ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST— 510(k) K882998

Name: FDA 510(k) clearance K882998
Creator: U.S. Food and Drug Administration
Published: 1988-09-07

Substantially Equivalent

Amtec Diagnostics International, Inc.

FDA 510(k) clearance K882998 for ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST, Substantially Equivalent on 1988-09-07. Applicant: Amtec Diagnostics International, Inc.. Device class: 2.

Clearance details

Applicant: Amtec Diagnostics International, Inc.
Product code: Code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 1988-07-18
Decision date: 1988-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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