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FDA 510(k)

ENZYMUN TEST TBG

K-Number: K862109 · 1986-06-30

ApplicantBoehringer Mannheim Corp.
Decision Date1986-06-30
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMUN TEST TBG 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 1986-06-30 under 510(k) number K862109. The device is classified under product code CEE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMUN TEST TBG?

ENZYMUN TEST TBG is a medical device that received FDA 510(k) clearance on 1986-06-30. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K862109.

When did ENZYMUN TEST TBG receive FDA 510(k) clearance?

ENZYMUN TEST TBG received FDA 510(k) clearance on 1986-06-30, under 510(k) number K862109.

Who is the listed applicant for ENZYMUN TEST TBG?

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 TBG?

The FDA product code for ENZYMUN TEST TBG is CEE.

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Other records listing Boehringer Mannheim Corp. 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.

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Related Devices (Code: CEE)

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.

K952284AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.K930010ACCESS THYROID UPTAKE ASSAYBio-Rad Laboratories, Inc.K910677IMMULITE(TM) T-UPTAKECirrus Diagnostics, Inc.K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.K900240DELFIA TBG KITPharmacia, Inc.K896991ENZYMUN TEST(R) TBKBoehringer Mannheim Corp.

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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