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FDA 510(k)

AUTOANTIBODY REAGENTS, AFT SYSTEM II

K-Number: K790280 · 1979-04-23

ApplicantCalbiochem-Behring Corp.
Decision Date1979-04-23
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOANTIBODY REAGENTS, AFT SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1979-04-23 under 510(k) number K790280. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOANTIBODY REAGENTS, AFT SYSTEM II?

AUTOANTIBODY REAGENTS, AFT SYSTEM II is a medical device that received FDA 510(k) clearance on 1979-04-23. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K790280.

When did AUTOANTIBODY REAGENTS, AFT SYSTEM II receive FDA 510(k) clearance?

AUTOANTIBODY REAGENTS, AFT SYSTEM II received FDA 510(k) clearance on 1979-04-23, under 510(k) number K790280.

Who is the listed applicant for AUTOANTIBODY REAGENTS, AFT SYSTEM II?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOANTIBODY REAGENTS, AFT SYSTEM II?

The FDA product code for AUTOANTIBODY REAGENTS, AFT SYSTEM II is DHN.

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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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