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FDA 510(k)

ADP ANA APPLEZYME

K-Number: K843745 · 1984-10-25

ApplicantApple Diagnostic Products
Decision Date1984-10-25
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADP ANA APPLEZYME is the device name listed in this FDA 510(k) record. The listed applicant is Apple Diagnostic Products. It received FDA 510(k) clearance on 1984-10-25 under 510(k) number K843745. 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 ADP ANA APPLEZYME?

ADP ANA APPLEZYME is a medical device that received FDA 510(k) clearance on 1984-10-25. The listed applicant is Apple Diagnostic Products. The 510(k) number is K843745.

When did ADP ANA APPLEZYME receive FDA 510(k) clearance?

ADP ANA APPLEZYME received FDA 510(k) clearance on 1984-10-25, under 510(k) number K843745.

Who is the listed applicant for ADP ANA APPLEZYME?

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

What is the FDA product code for ADP ANA APPLEZYME?

The FDA product code for ADP ANA APPLEZYME is LJM.

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Other records listing Apple Diagnostic Products 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.

K844287ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDIIK843120APPLELISA CHLAMYDIA TRACHOMATIS ANTIK842707ADP NDNA IFA TESTK842183ADP ANA IFA TESTK834241ANA APPLELISAK834242ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS

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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

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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