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FDA 510(k)

TRU-TRAX

K-Number: K894851 · 1989-09-29

ApplicantHumagen, Inc.
Decision Date1989-09-29
Product CodeGIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRU-TRAX is the device name listed in this FDA 510(k) record. The listed applicant is Humagen, Inc.. It received FDA 510(k) clearance on 1989-09-29 under 510(k) number K894851. The device is classified under product code GIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRU-TRAX?

TRU-TRAX is a medical device that received FDA 510(k) clearance on 1989-09-29. The listed applicant is Humagen, Inc.. The 510(k) number is K894851.

When did TRU-TRAX receive FDA 510(k) clearance?

TRU-TRAX received FDA 510(k) clearance on 1989-09-29, under 510(k) number K894851.

Who is the listed applicant for TRU-TRAX?

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

What is the FDA product code for TRU-TRAX?

The FDA product code for TRU-TRAX is GIO.

Related Devices (Code: GIO)

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.

K972969QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.K941291MONOJECT SAMPLETTE SEPARATOR TUBESherwood Medical Co.K885324HEMA(PRO)TEC(TION)Medical Products Search, Inc.K885138CAPILLARY TUBE, BLOOD COLLECTIONCoeur Laboratories, Inc.K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBESafe-Tec Clinical Products, Inc.K881262CARAWAY TUBES, HEPARIN AND PLAINHelps Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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