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FDA 510(k)

ENZYGNOST(R) TAT REAGENTS

K-Number: K880700 · 1988-04-27

ApplicantBehring Diagnostics, Inc.
Decision Date1988-04-27
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST(R) TAT REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-04-27 under 510(k) number K880700. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYGNOST(R) TAT REAGENTS?

ENZYGNOST(R) TAT REAGENTS is a medical device that received FDA 510(k) clearance on 1988-04-27. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K880700.

When did ENZYGNOST(R) TAT REAGENTS receive FDA 510(k) clearance?

ENZYGNOST(R) TAT REAGENTS received FDA 510(k) clearance on 1988-04-27, under 510(k) number K880700.

Who is the listed applicant for ENZYGNOST(R) TAT REAGENTS?

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

What is the FDA product code for ENZYGNOST(R) TAT REAGENTS?

The FDA product code for ENZYGNOST(R) TAT REAGENTS is JBQ.

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Related Devices (Code: JBQ)

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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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