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FDA 510(k)

SEROFAST

K-Number: K903958 · 1990-12-21

ApplicantIntl. Mycoplasma/Mdc Assoc.
Decision Date1990-12-21
Product CodeGSA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEROFAST is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Mycoplasma/Mdc Assoc.. It received FDA 510(k) clearance on 1990-12-21 under 510(k) number K903958. The device is classified under product code GSA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEROFAST?

SEROFAST is a medical device that received FDA 510(k) clearance on 1990-12-21. The listed applicant is Intl. Mycoplasma/Mdc Assoc.. The 510(k) number is K903958.

When did SEROFAST receive FDA 510(k) clearance?

SEROFAST received FDA 510(k) clearance on 1990-12-21, under 510(k) number K903958.

Who is the listed applicant for SEROFAST?

The FDA 510(k) record lists Intl. Mycoplasma/Mdc Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEROFAST?

The FDA product code for SEROFAST is GSA.

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Related Devices (Code: GSA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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