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FDA 510(k)

RESP. SYNCYTIAL-FA LABELLED PRESERUM

K-Number: K770808 · 1977-05-20

ApplicantFlow Laboratories, Inc.
Decision Date1977-05-20
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESP. SYNCYTIAL-FA LABELLED PRESERUM is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1977-05-20 under 510(k) number K770808. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESP. SYNCYTIAL-FA LABELLED PRESERUM?

RESP. SYNCYTIAL-FA LABELLED PRESERUM is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K770808.

When did RESP. SYNCYTIAL-FA LABELLED PRESERUM receive FDA 510(k) clearance?

RESP. SYNCYTIAL-FA LABELLED PRESERUM received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770808.

Who is the listed applicant for RESP. SYNCYTIAL-FA LABELLED PRESERUM?

The FDA 510(k) record lists Flow Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESP. SYNCYTIAL-FA LABELLED PRESERUM?

The FDA product code for RESP. SYNCYTIAL-FA LABELLED PRESERUM is GQG.

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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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