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FDA 510(k)

ADP NDNA IFA TEST

K-Number: K842707 · 1984-08-21

ApplicantApple Diagnostic Products
Decision Date1984-08-21
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADP NDNA IFA TEST 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 1984-08-21 under 510(k) number K842707. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADP NDNA IFA TEST?

ADP NDNA IFA TEST is a medical device that received FDA 510(k) clearance on 1984-08-21. The listed applicant is Apple Diagnostic Products. The 510(k) number is K842707.

When did ADP NDNA IFA TEST receive FDA 510(k) clearance?

ADP NDNA IFA TEST received FDA 510(k) clearance on 1984-08-21, under 510(k) number K842707.

Who is the listed applicant for ADP NDNA IFA TEST?

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 NDNA IFA TEST?

The FDA product code for ADP NDNA IFA TEST is KTL.

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 GONDIIK843745ADP ANA APPLEZYMEK843120APPLELISA CHLAMYDIA TRACHOMATIS ANTIK842183ADP ANA IFA TESTK834241ANA APPLELISAK834242ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS

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Related Devices (Code: KTL)

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.

K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus ScientificK203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc.K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K011068RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LRhigene, 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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