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FDA 510(k)

ANA PROFILE I

K-Number: K932424 · 1993-08-10

ApplicantApotex Scientific, Inc.
Decision Date1993-08-10
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA PROFILE I is the device name listed in this FDA 510(k) record. The listed applicant is Apotex Scientific, Inc.. It received FDA 510(k) clearance on 1993-08-10 under 510(k) number K932424. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA PROFILE I?

ANA PROFILE I is a medical device that received FDA 510(k) clearance on 1993-08-10. The listed applicant is Apotex Scientific, Inc.. The 510(k) number is K932424.

When did ANA PROFILE I receive FDA 510(k) clearance?

ANA PROFILE I received FDA 510(k) clearance on 1993-08-10, under 510(k) number K932424.

Who is the listed applicant for ANA PROFILE I?

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

What is the FDA product code for ANA PROFILE I?

The FDA product code for ANA PROFILE I is LJM.

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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