FDA 510(k)

ENZYMUN TEST(R) T4 (TOTAL THYROXINE)

K-Number: K901086 · 1990-03-30

Decision Date1990-03-30

Product CodeKLT

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ENZYMUN TEST(R) T4 (TOTAL THYROXINE) is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1990-03-30 under 510(k) number K901086. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMUN TEST(R) T4 (TOTAL THYROXINE)?

ENZYMUN TEST(R) T4 (TOTAL THYROXINE) is a medical device that received FDA 510(k) clearance on 1990-03-30. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K901086.

When did ENZYMUN TEST(R) T4 (TOTAL THYROXINE) receive FDA 510(k) clearance?

ENZYMUN TEST(R) T4 (TOTAL THYROXINE) received FDA 510(k) clearance on 1990-03-30, under 510(k) number K901086.

Who is the listed applicant for ENZYMUN TEST(R) T4 (TOTAL THYROXINE)?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYMUN TEST(R) T4 (TOTAL THYROXINE)?

The FDA product code for ENZYMUN TEST(R) T4 (TOTAL THYROXINE) is KLT.

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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.