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FDA 510(k)

AFT SYSTEM

K-Number: K771993 · 1977-11-02

ApplicantCalbiochem
Decision Date1977-11-02
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AFT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem. It received FDA 510(k) clearance on 1977-11-02 under 510(k) number K771993. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFT SYSTEM?

AFT SYSTEM is a medical device that received FDA 510(k) clearance on 1977-11-02. The listed applicant is Calbiochem. The 510(k) number is K771993.

When did AFT SYSTEM receive FDA 510(k) clearance?

AFT SYSTEM received FDA 510(k) clearance on 1977-11-02, under 510(k) number K771993.

Who is the listed applicant for AFT SYSTEM?

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

What is the FDA product code for AFT SYSTEM?

The FDA product code for AFT SYSTEM is DBM.

Related Clinical Trials

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Other records listing Calbiochem as applicant

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.

K760786ENZYMATIC LIPASE MAX-PACK REAGENTK760366REAGENT, Y-GT MAX-PACK

Related Devices (Code: DBM)

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

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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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