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FDA 510(k)

CELLOGNOST SYPHILIS H

K-Number: K896410 · 1990-05-15

ApplicantBehring Diagnostics, Inc.
Decision Date1990-05-15
Product CodeGMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CELLOGNOST SYPHILIS H 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 1990-05-15 under 510(k) number K896410. The device is classified under product code GMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLOGNOST SYPHILIS H?

CELLOGNOST SYPHILIS H is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K896410.

When did CELLOGNOST SYPHILIS H receive FDA 510(k) clearance?

CELLOGNOST SYPHILIS H received FDA 510(k) clearance on 1990-05-15, under 510(k) number K896410.

Who is the listed applicant for CELLOGNOST SYPHILIS H?

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 CELLOGNOST SYPHILIS H?

The FDA product code for CELLOGNOST SYPHILIS H is GMT.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: GMT)

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K971502SERODIA TP-PAScimedx Tekfile ServicesK911640OLYMPUS PK TP(TM) SYSTEM, MODIFICATIONOlympus Corp.K911266MODIFIED PK TP CONTROLOlympus Corp.K905038OLYMPUS PK-TP ABSORBENT KITFujirebio America, Inc.K893124OLYMPUS PK(TM) TPFujirebio Diagnostics,Inc.K791897BACTO-HATTSDifco Laboratories, Inc.

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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