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FDA 510(k)

TSH CONTROL

K-Number: K915325 · 1992-03-02

ApplicantPolymedco, Inc.
Decision Date1992-03-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K915325. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSH CONTROL?

TSH CONTROL is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Polymedco, Inc.. The 510(k) number is K915325.

When did TSH CONTROL receive FDA 510(k) clearance?

TSH CONTROL received FDA 510(k) clearance on 1992-03-02, under 510(k) number K915325.

Who is the listed applicant for TSH CONTROL?

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

What is the FDA product code for TSH CONTROL?

The FDA product code for TSH CONTROL is JJX.

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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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