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FDA 510(k)

MEDICA IIF-ANTI-THYROID ANTIBODY TEST

K-Number: K843343 · 1984-10-22

ApplicantMedical Diagnostics, Ca.
Decision Date1984-10-22
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MEDICA IIF-ANTI-THYROID ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostics, Ca.. It received FDA 510(k) clearance on 1984-10-22 under 510(k) number K843343. 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 MEDICA IIF-ANTI-THYROID ANTIBODY TEST?

MEDICA IIF-ANTI-THYROID ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1984-10-22. The listed applicant is Medical Diagnostics, Ca.. The 510(k) number is K843343.

When did MEDICA IIF-ANTI-THYROID ANTIBODY TEST receive FDA 510(k) clearance?

MEDICA IIF-ANTI-THYROID ANTIBODY TEST received FDA 510(k) clearance on 1984-10-22, under 510(k) number K843343.

Who is the listed applicant for MEDICA IIF-ANTI-THYROID ANTIBODY TEST?

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

What is the FDA product code for MEDICA IIF-ANTI-THYROID ANTIBODY TEST?

The FDA product code for MEDICA IIF-ANTI-THYROID ANTIBODY TEST is JZO.

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Other records listing Medical Diagnostics, Ca. 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.

K853140MDI QUIK TEST NARCOTICS DRUG SCREENK843900FOCUSCOPE UNIVERSAL SYSTEMK831100MEDICA IIF-MULTIPLE ANTIBODY TEST KIT

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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