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FDA 510(k)

ASTRA-VAC

K-Number: K782115 · 1979-02-01

ApplicantAb Astra
Decision Date1979-02-01
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASTRA-VAC is the device name listed in this FDA 510(k) record. The listed applicant is Ab Astra. It received FDA 510(k) clearance on 1979-02-01 under 510(k) number K782115. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRA-VAC?

ASTRA-VAC is a medical device that received FDA 510(k) clearance on 1979-02-01. The listed applicant is Ab Astra. The 510(k) number is K782115.

When did ASTRA-VAC receive FDA 510(k) clearance?

ASTRA-VAC received FDA 510(k) clearance on 1979-02-01, under 510(k) number K782115.

Who is the listed applicant for ASTRA-VAC?

The FDA 510(k) record lists Ab Astra as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTRA-VAC?

The FDA product code for ASTRA-VAC is GCY.

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Related Devices (Code: GCY)

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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