QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024— 510(k) K991063

Name: FDA 510(k) clearance K991063
Creator: U.S. Food and Drug Administration
Published: 1999-09-21

Substantially Equivalent

Immunetics, Inc.

FDA 510(k) clearance K991063 for QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024, Substantially Equivalent on 1999-09-21. Applicant: Immunetics, Inc.. Device class: 2.

Clearance details

Applicant: Immunetics, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1999-03-31
Decision date: 1999-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge,, MA, US

Download summary PDF View on FDA.gov ↗

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