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FDA 510(k)

COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1

K-Number: K874873 · 1988-02-10

ApplicantDiagnostic Products Corp.
Decision Date1988-02-10
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1988-02-10 under 510(k) number K874873. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1?

COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 is a medical device that received FDA 510(k) clearance on 1988-02-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K874873.

When did COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 receive FDA 510(k) clearance?

COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 received FDA 510(k) clearance on 1988-02-10, under 510(k) number K874873.

Who is the listed applicant for COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1?

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

What is the FDA product code for COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1?

The FDA product code for COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 is DHN.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: DHN)

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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.KgK160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC

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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