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FDA 510(k)

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

K-Number: K963525 · 1996-11-07

ApplicantShield Diagnostics, Ltd.
Decision Date1996-11-07
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 1996-11-07 under 510(k) number K963525. 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 DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT?

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT is a medical device that received FDA 510(k) clearance on 1996-11-07. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K963525.

When did DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT receive FDA 510(k) clearance?

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT received FDA 510(k) clearance on 1996-11-07, under 510(k) number K963525.

Who is the listed applicant for DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT?

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

What is the FDA product code for DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT?

The FDA product code for DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT is DBL.

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Other records listing Shield Diagnostics, Ltd. 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.

K000398SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200K982879SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAYK980885SHIELD ACTIVATED FACTOR XII (ELISA) ASSAYK972981SHIELD HELICO-G2 ELISA KITK962825SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAYK961515QUANTASE PHENYLALANINE ASSAY

View all 27 devices →

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. GellerK955431RIT LIVER, KIDNEY, STOMACH IFA KITThe Binding Site, 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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