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FDA 510(k)

AFT SYSTEM PROFICIENCY TESTING PROGRAM

K-Number: K820088 · 1982-01-26

ApplicantCalbiochem-Behring Corp.
Decision Date1982-01-26
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AFT SYSTEM PROFICIENCY TESTING PROGRAM 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 1982-01-26 under 510(k) number K820088. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFT SYSTEM PROFICIENCY TESTING PROGRAM?

AFT SYSTEM PROFICIENCY TESTING PROGRAM is a medical device that received FDA 510(k) clearance on 1982-01-26. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K820088.

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

AFT SYSTEM PROFICIENCY TESTING PROGRAM received FDA 510(k) clearance on 1982-01-26, under 510(k) number K820088.

Who is the listed applicant for AFT SYSTEM PROFICIENCY TESTING PROGRAM?

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 AFT SYSTEM PROFICIENCY TESTING PROGRAM?

The FDA product code for AFT SYSTEM PROFICIENCY TESTING PROGRAM is DBL.

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Other records listing Calbiochem-Behring Corp. 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.

K831811REVOLUTION RADIAL IMMUNODIFFUSION PLATEK831036ENA TEST KIT SM & RNP AUTO ANTIBODYK830214AFT SYSTEM IIIK820812CREATINE KINASE-MB KITK813493ENZYGNOST TM RUBELLA IGMK812458PADAC

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Related Devices (Code: DBL)

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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