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FDA 510(k)

THYROGLOBULIN ASSAY SYSTEM

K-Number: K972190 · 1997-07-14

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date1997-07-14
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THYROGLOBULIN ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Laboratory Products Co., Ltd.. It received FDA 510(k) clearance on 1997-07-14 under 510(k) number K972190. 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 THYROGLOBULIN ASSAY SYSTEM?

THYROGLOBULIN ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K972190.

When did THYROGLOBULIN ASSAY SYSTEM receive FDA 510(k) clearance?

THYROGLOBULIN ASSAY SYSTEM received FDA 510(k) clearance on 1997-07-14, under 510(k) number K972190.

Who is the listed applicant for THYROGLOBULIN ASSAY SYSTEM?

The FDA 510(k) record lists American Laboratory Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THYROGLOBULIN ASSAY SYSTEM?

The FDA product code for THYROGLOBULIN ASSAY SYSTEM is JZO.

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Other records listing American Laboratory Products Co., Ltd. as applicant

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Related Devices (Code: JZO)

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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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