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FDA 510(k)

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK

K-Number: K944697 · 1995-02-22

ApplicantOrganon Teknika Corp.
Decision Date1995-02-22
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1995-02-22 under 510(k) number K944697. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK?

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is Organon Teknika Corp.. The 510(k) number is K944697.

When did AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK receive FDA 510(k) clearance?

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK received FDA 510(k) clearance on 1995-02-22, under 510(k) number K944697.

Who is the listed applicant for AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK?

The FDA product code for AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK is CEC.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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