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FDA 510(k)

TRANSETTE SYSTEM/COLLECTION & TRANSP

K-Number: K802563 · 1980-10-31

ApplicantInolex Corp./Div of Biomedical
Decision Date1980-10-31
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRANSETTE SYSTEM/COLLECTION & TRANSP is the device name listed in this FDA 510(k) record. The listed applicant is Inolex Corp./Div of Biomedical. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802563. The device is classified under product code JTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSETTE SYSTEM/COLLECTION & TRANSP?

TRANSETTE SYSTEM/COLLECTION & TRANSP is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Inolex Corp./Div of Biomedical. The 510(k) number is K802563.

When did TRANSETTE SYSTEM/COLLECTION & TRANSP receive FDA 510(k) clearance?

TRANSETTE SYSTEM/COLLECTION & TRANSP received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802563.

Who is the listed applicant for TRANSETTE SYSTEM/COLLECTION & TRANSP?

The FDA 510(k) record lists Inolex Corp./Div of Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSETTE SYSTEM/COLLECTION & TRANSP?

The FDA product code for TRANSETTE SYSTEM/COLLECTION & TRANSP is JTW.

Related Clinical Trials

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.

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Other records listing Inolex Corp./Div of Biomedical 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.

K771703ENTERIC 20

Related Devices (Code: JTW)

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.

K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMCopan Flock TechnologiesK061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K022874GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEMSierra Diagnostic, LLCK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)Trek Diagnostic Systems, 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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