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FDA 510(k)

DOCUMENT THYROID CAL*VER

K-Number: K992034 · 1999-07-23

ApplicantCasco-Nerl Diagnostics Corporation (Maine)
Decision Date1999-07-23
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT THYROID CAL*VER is the device name listed in this FDA 510(k) record. The listed applicant is Casco-Nerl Diagnostics Corporation (Maine). It received FDA 510(k) clearance on 1999-07-23 under 510(k) number K992034. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCUMENT THYROID CAL*VER?

DOCUMENT THYROID CAL*VER is a medical device that received FDA 510(k) clearance on 1999-07-23. The listed applicant is Casco-Nerl Diagnostics Corporation (Maine). The 510(k) number is K992034.

When did DOCUMENT THYROID CAL*VER receive FDA 510(k) clearance?

DOCUMENT THYROID CAL*VER received FDA 510(k) clearance on 1999-07-23, under 510(k) number K992034.

Who is the listed applicant for DOCUMENT THYROID CAL*VER?

The FDA 510(k) record lists Casco-Nerl Diagnostics Corporation (Maine) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOCUMENT THYROID CAL*VER?

The FDA product code for DOCUMENT THYROID CAL*VER is JJY.

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Other records listing Casco-Nerl Diagnostics Corporation (Maine) 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.

K002174DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3K993014MODIFICATION TO DOCUMENT THYROID CAL.VER

Related Devices (Code: JJY)

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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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