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FDA 510(k)

ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN

K-Number: K840867 · 1984-05-11

ApplicantIntl. Diagnostic Technology
Decision Date1984-05-11
Product CodeDEI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN 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 1984-05-11 under 510(k) number K840867. The device is classified under product code DEI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN?

ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN is a medical device that received FDA 510(k) clearance on 1984-05-11. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K840867.

When did ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN receive FDA 510(k) clearance?

ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN received FDA 510(k) clearance on 1984-05-11, under 510(k) number K840867.

Who is the listed applicant for ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN?

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 ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN?

The FDA product code for ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN is DEI.

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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 KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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Related Devices (Code: DEI)

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.

K772250ALPHA-1-ANTITRYPSIN NEPHEL. ASSAYKallestad Laboratories, Inc.

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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