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FDA 510(k)

CHEMO-SPIKE II RECONSTITUTION DEVICE

K-Number: K974431 · 1998-01-08

ApplicantMedi-Dose, Inc.
Decision Date1998-01-08
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHEMO-SPIKE II RECONSTITUTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Dose, Inc.. It received FDA 510(k) clearance on 1998-01-08 under 510(k) number K974431. 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 CHEMO-SPIKE II RECONSTITUTION DEVICE?

CHEMO-SPIKE II RECONSTITUTION DEVICE is a medical device that received FDA 510(k) clearance on 1998-01-08. The listed applicant is Medi-Dose, Inc.. The 510(k) number is K974431.

When did CHEMO-SPIKE II RECONSTITUTION DEVICE receive FDA 510(k) clearance?

CHEMO-SPIKE II RECONSTITUTION DEVICE received FDA 510(k) clearance on 1998-01-08, under 510(k) number K974431.

Who is the listed applicant for CHEMO-SPIKE II RECONSTITUTION DEVICE?

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

What is the FDA product code for CHEMO-SPIKE II RECONSTITUTION DEVICE?

The FDA product code for CHEMO-SPIKE II RECONSTITUTION DEVICE is LHI.

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Other records listing Medi-Dose, Inc. 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.

K952518SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICEK936015DISPOSABLE DISC FILTERK9425322 MICRON AIR ELIMINATING FILTER

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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