FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST— 510(k) K931557

Name: FDA 510(k) clearance K931557
Creator: U.S. Food and Drug Administration
Published: 1994-03-11

Substantially Equivalent

Fuller Laboratories, Inc.

FDA 510(k) clearance K931557 for FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST, Substantially Equivalent on 1994-03-11. Applicant: Fuller Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Fuller Laboratories, Inc.
Product code: Code GRZ
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1993-03-30
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

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