SEROFAST— 510(k) K903958

Substantially Equivalent

Intl. Mycoplasma/Mdc Assoc.

FDA 510(k) clearance K903958 for SEROFAST, Substantially Equivalent on 1990-12-21. Applicant: Intl. Mycoplasma/Mdc Assoc.. Device class: 1.

Clearance details

Applicant: Intl. Mycoplasma/Mdc Assoc.
Product code: Code GSA
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1990-08-28
Decision date: 1990-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.