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FDA 510(k)

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT

K-Number: K921183 · 1992-06-19

ApplicantShield Diagnostics, Ltd.
Decision Date1992-06-19
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY 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 1992-06-19 under 510(k) number K921183. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT?

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K921183.

When did DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT receive FDA 510(k) clearance?

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT received FDA 510(k) clearance on 1992-06-19, under 510(k) number K921183.

Who is the listed applicant for DIASTAT ANTI-MITOCHONDRIAL ANTIBODY 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-MITOCHONDRIAL ANTIBODY KIT?

The FDA product code for DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT is DBM.

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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) ASSAYK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

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Related Devices (Code: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, Inc.

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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