INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530— 510(k) K960434

Name: FDA 510(k) clearance K960434
Creator: U.S. Food and Drug Administration
Published: 1996-10-17

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K960434 for INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530, Substantially Equivalent on 1996-10-17. Applicant: Incstar Corp.. Device class: 2.

Clearance details

Applicant: Incstar Corp.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1996-01-31
Decision date: 1996-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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