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FDA 510(k)

BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM

K-Number: K872845 · 1987-08-17

ApplicantBion Ent., Ltd.
Decision Date1987-08-17
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1987-08-17 under 510(k) number K872845. 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 BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM?

BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM is a medical device that received FDA 510(k) clearance on 1987-08-17. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K872845.

When did BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM receive FDA 510(k) clearance?

BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM received FDA 510(k) clearance on 1987-08-17, under 510(k) number K872845.

Who is the listed applicant for BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM?

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

What is the FDA product code for BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM?

The FDA product code for BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM is DHN.

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Other records listing Bion Ent., Ltd. as applicant

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K926066BION MUMPS-G ANTIBODY TEST SYSTEMK901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894622VARICELLA ZOSTER VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENK894624MUMPS VIRUSK894623RESPIRATORY SYNCYTIAL VIRUS

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Related Devices (Code: 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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