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FDA 510(k)

ENZYMUN TEST(R) TSH-S

K-Number: K900277 · 1990-04-11

ApplicantBoehringer Mannheim Corp.
Decision Date1990-04-11
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMUN TEST(R) TSH-S 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 1990-04-11 under 510(k) number K900277. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMUN TEST(R) TSH-S?

ENZYMUN TEST(R) TSH-S is a medical device that received FDA 510(k) clearance on 1990-04-11. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K900277.

When did ENZYMUN TEST(R) TSH-S receive FDA 510(k) clearance?

ENZYMUN TEST(R) TSH-S received FDA 510(k) clearance on 1990-04-11, under 510(k) number K900277.

Who is the listed applicant for ENZYMUN TEST(R) TSH-S?

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) TSH-S?

The FDA product code for ENZYMUN TEST(R) TSH-S is JLW.

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Related Devices (Code: JLW)

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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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