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FDA 510(k)

ANTI-GBM ANTIBODIES QUANTITATIVE KIT

K-Number: K904181 · 1991-09-10

ApplicantBiochemical Diagnostic, Inc.
Decision Date1991-09-10
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-GBM ANTIBODIES QUANTITATIVE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Diagnostic, Inc.. It received FDA 510(k) clearance on 1991-09-10 under 510(k) number K904181. 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 ANTI-GBM ANTIBODIES QUANTITATIVE KIT?

ANTI-GBM ANTIBODIES QUANTITATIVE KIT is a medical device that received FDA 510(k) clearance on 1991-09-10. The listed applicant is Biochemical Diagnostic, Inc.. The 510(k) number is K904181.

When did ANTI-GBM ANTIBODIES QUANTITATIVE KIT receive FDA 510(k) clearance?

ANTI-GBM ANTIBODIES QUANTITATIVE KIT received FDA 510(k) clearance on 1991-09-10, under 510(k) number K904181.

Who is the listed applicant for ANTI-GBM ANTIBODIES QUANTITATIVE KIT?

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

What is the FDA product code for ANTI-GBM ANTIBODIES QUANTITATIVE KIT?

The FDA product code for ANTI-GBM ANTIBODIES QUANTITATIVE KIT 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 Biochemical Diagnostic, 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.

K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLK050328PREGNANCY-SKREENK925586DETECTABUSE(TM)K841831CANNU-SKREEN-PRELIMINARY

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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