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FDA 510(k)

DIASTAT ANTI-THYROGLOBULIN KIT

K-Number: K952183 · 1995-06-30

ApplicantShield Diagnostics, Ltd.
Decision Date1995-06-30
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIASTAT ANTI-THYROGLOBULIN 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 1995-06-30 under 510(k) number K952183. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASTAT ANTI-THYROGLOBULIN KIT?

DIASTAT ANTI-THYROGLOBULIN KIT is a medical device that received FDA 510(k) clearance on 1995-06-30. The listed applicant is Shield Diagnostics, Ltd.. The 510(k) number is K952183.

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

DIASTAT ANTI-THYROGLOBULIN KIT received FDA 510(k) clearance on 1995-06-30, under 510(k) number K952183.

Who is the listed applicant for DIASTAT ANTI-THYROGLOBULIN 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-THYROGLOBULIN KIT?

The FDA product code for DIASTAT ANTI-THYROGLOBULIN KIT is JZO.

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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: JZO)

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.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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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