IMMUNETICS C6 LYME ELISA KIT— 510(k) K003754

Substantially Equivalent

Immunetics, Inc.

FDA 510(k) clearance K003754 for IMMUNETICS C6 LYME ELISA KIT, Substantially Equivalent on 2001-05-10. 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: 2000-12-05
Decision date: 2001-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge,, MA, US

Download summary PDF View on FDA.gov ↗

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