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FDA 510(k)

PARA 1 SENDAI HEMAGGLUTININ

K-Number: K812365 · 1981-09-09

ApplicantDutchland Laboratories, Inc.
Decision Date1981-09-09
Product CodeGQR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARA 1 SENDAI HEMAGGLUTININ is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1981-09-09 under 510(k) number K812365. The device is classified under product code GQR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA 1 SENDAI HEMAGGLUTININ?

PARA 1 SENDAI HEMAGGLUTININ is a medical device that received FDA 510(k) clearance on 1981-09-09. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K812365.

When did PARA 1 SENDAI HEMAGGLUTININ receive FDA 510(k) clearance?

PARA 1 SENDAI HEMAGGLUTININ received FDA 510(k) clearance on 1981-09-09, under 510(k) number K812365.

Who is the listed applicant for PARA 1 SENDAI HEMAGGLUTININ?

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

What is the FDA product code for PARA 1 SENDAI HEMAGGLUTININ?

The FDA product code for PARA 1 SENDAI HEMAGGLUTININ is GQR.

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Official Source

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

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