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FDA 510(k)

ENZYMUN TEST(R) TBK

K-Number: K896991 · 1990-03-01

ApplicantBoehringer Mannheim Corp.
Decision Date1990-03-01
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMUN TEST(R) TBK 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 1990-03-01 under 510(k) number K896991. 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(R) TBK?

ENZYMUN TEST(R) TBK is a medical device that received FDA 510(k) clearance on 1990-03-01. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K896991.

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

ENZYMUN TEST(R) TBK received FDA 510(k) clearance on 1990-03-01, under 510(k) number K896991.

Who is the listed applicant for ENZYMUN TEST(R) TBK?

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) TBK?

The FDA product code for ENZYMUN TEST(R) TBK 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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.K893469AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KITAmersham 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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