PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS— 510(k) K853554

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K853554 for PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS, Substantially Equivalent on 1985-11-26. Applicant: Kallestad Laboratories, Inc..

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code LIQ
Advisory panel: Microbiology
Date received: 1985-08-26
Decision date: 1985-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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