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FDA 510(k)

TAKY-SPIKE PLUS

K-Number: K974198 · 1997-12-22

ApplicantClinico
Decision Date1997-12-22
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TAKY-SPIKE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Clinico. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K974198. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAKY-SPIKE PLUS?

TAKY-SPIKE PLUS is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Clinico. The 510(k) number is K974198.

When did TAKY-SPIKE PLUS receive FDA 510(k) clearance?

TAKY-SPIKE PLUS received FDA 510(k) clearance on 1997-12-22, under 510(k) number K974198.

Who is the listed applicant for TAKY-SPIKE PLUS?

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

What is the FDA product code for TAKY-SPIKE PLUS?

The FDA product code for TAKY-SPIKE PLUS is LHI.

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Other records listing Clinico as applicant

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Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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