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FDA 510(k)

AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)

K-Number: K883915 · 1988-10-19

ApplicantImmco Diagnostics, Inc.
Decision Date1988-10-19
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K883915. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)?

AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K883915.

When did AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) receive FDA 510(k) clearance?

AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) received FDA 510(k) clearance on 1988-10-19, under 510(k) number K883915.

Who is the listed applicant for AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)?

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

What is the FDA product code for AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)?

The FDA product code for AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) is DBL.

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Related Devices (Code: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITEuro-Diagnostica ABK971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. GellerK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.

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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