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FDA 510(k)

FIAX HAPTOGLOBIN TEST KIT

K-Number: K843570 · 1984-10-05

ApplicantIntl. Diagnostic Technology
Decision Date1984-10-05
Product CodeDAB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX HAPTOGLOBIN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1984-10-05 under 510(k) number K843570. The device is classified under product code DAB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX HAPTOGLOBIN TEST KIT?

FIAX HAPTOGLOBIN TEST KIT is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K843570.

When did FIAX HAPTOGLOBIN TEST KIT receive FDA 510(k) clearance?

FIAX HAPTOGLOBIN TEST KIT received FDA 510(k) clearance on 1984-10-05, under 510(k) number K843570.

Who is the listed applicant for FIAX HAPTOGLOBIN TEST KIT?

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

What is the FDA product code for FIAX HAPTOGLOBIN TEST KIT?

The FDA product code for FIAX HAPTOGLOBIN TEST KIT is DAB.

Related Clinical Trials

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KITK841174RUBELLA ANTIBODY FLUOROIMMUNOASSAY

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Related Devices (Code: DAB)

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.

K913670HAPTOGLOBIN IMMUNOLOGICAL TEST KITThe Binding Site, Ltd.K772078RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBINGelman Instrument Co.

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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