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FDA 510(k)

MULTIPLE AUTO ANTIBODY TEST

K-Number: K791996 · 1980-01-16

ApplicantMeda Stat Diagnostics, Inc.
Decision Date1980-01-16
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MULTIPLE AUTO ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Meda Stat Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K791996. 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 MULTIPLE AUTO ANTIBODY TEST?

MULTIPLE AUTO ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Meda Stat Diagnostics, Inc.. The 510(k) number is K791996.

When did MULTIPLE AUTO ANTIBODY TEST receive FDA 510(k) clearance?

MULTIPLE AUTO ANTIBODY TEST received FDA 510(k) clearance on 1980-01-16, under 510(k) number K791996.

Who is the listed applicant for MULTIPLE AUTO ANTIBODY TEST?

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

What is the FDA product code for MULTIPLE AUTO ANTIBODY TEST?

The FDA product code for MULTIPLE AUTO ANTIBODY TEST is DBL.

Related Clinical Trials

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.

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Other records listing Meda Stat Diagnostics, Inc. 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.

K791995ANTI NUCLEAR ANTIBODY TESTK780615BLOOD CULTURE MEDIA

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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