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FDA 510(k)

ADD-A-VIAL SOLUTION TRANSFER DEVICE

K-Number: K843639 · 1985-01-14

ApplicantAmerican Mcgaw
Decision Date1985-01-14
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ADD-A-VIAL SOLUTION TRANSFER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is American Mcgaw. It received FDA 510(k) clearance on 1985-01-14 under 510(k) number K843639. 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 ADD-A-VIAL SOLUTION TRANSFER DEVICE?

ADD-A-VIAL SOLUTION TRANSFER DEVICE is a medical device that received FDA 510(k) clearance on 1985-01-14. The listed applicant is American Mcgaw. The 510(k) number is K843639.

When did ADD-A-VIAL SOLUTION TRANSFER DEVICE receive FDA 510(k) clearance?

ADD-A-VIAL SOLUTION TRANSFER DEVICE received FDA 510(k) clearance on 1985-01-14, under 510(k) number K843639.

Who is the listed applicant for ADD-A-VIAL SOLUTION TRANSFER DEVICE?

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

What is the FDA product code for ADD-A-VIAL SOLUTION TRANSFER DEVICE?

The FDA product code for ADD-A-VIAL SOLUTION TRANSFER DEVICE is LHI.

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Other records listing American Mcgaw 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.

K853549MCGAW/DROP WATCH FLOW MONITORK843954MIXING CONTAINERK841729ACCUPRO ENTERAL FEEDING PUMPK840388PAB IV CONTAINERK840212CONCENTRATED PLATELET ADMIN. SETK831716CAPD - CATHETER ADAPTER

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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

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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