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FDA 510(k)

TRANSTAT-CMV(TM)

K-Number: K903308 · 1990-12-04

ApplicantAb Sangtec Medical
Decision Date1990-12-04
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRANSTAT-CMV(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Ab Sangtec Medical. It received FDA 510(k) clearance on 1990-12-04 under 510(k) number K903308. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSTAT-CMV(TM)?

TRANSTAT-CMV(TM) is a medical device that received FDA 510(k) clearance on 1990-12-04. The listed applicant is Ab Sangtec Medical. The 510(k) number is K903308.

When did TRANSTAT-CMV(TM) receive FDA 510(k) clearance?

TRANSTAT-CMV(TM) received FDA 510(k) clearance on 1990-12-04, under 510(k) number K903308.

Who is the listed applicant for TRANSTAT-CMV(TM)?

The FDA 510(k) record lists Ab Sangtec Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSTAT-CMV(TM)?

The FDA product code for TRANSTAT-CMV(TM) is LFX.

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Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

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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