CELLMATICS RSV DETECTION SYSTEM— 510(k) K862321

Name: FDA 510(k) clearance K862321
Creator: U.S. Food and Drug Administration
Published: 1986-08-21

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K862321 for CELLMATICS RSV DETECTION SYSTEM, Substantially Equivalent on 1986-08-21. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1986-06-18
Decision date: 1986-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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