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FDA 510(k)

FNA THYROID BIOPSY KIT

K-Number: K870863 · 1987-05-08

Decision Date1987-05-08
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FNA THYROID BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Flint Laboratories Div. Travenol. It received FDA 510(k) clearance on 1987-05-08 under 510(k) number K870863. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FNA THYROID BIOPSY KIT?

FNA THYROID BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1987-05-08. The listed applicant is Flint Laboratories Div. Travenol. The 510(k) number is K870863.

When did FNA THYROID BIOPSY KIT receive FDA 510(k) clearance?

FNA THYROID BIOPSY KIT received FDA 510(k) clearance on 1987-05-08, under 510(k) number K870863.

Who is the listed applicant for FNA THYROID BIOPSY KIT?

The FDA 510(k) record lists Flint Laboratories Div. Travenol as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FNA THYROID BIOPSY KIT?

The FDA product code for FNA THYROID BIOPSY KIT is FMI.

Related Clinical Trials

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.

Related Devices (Code: FMI)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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