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FDA 510(k)

GENT-L-KARE STERILE I.V. START KIT

K-Number: K844255 · 1984-12-19

ApplicantGeneva Laboratories, Inc.
Decision Date1984-12-19
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENT-L-KARE STERILE I.V. START KIT is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1984-12-19 under 510(k) number K844255. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENT-L-KARE STERILE I.V. START KIT?

GENT-L-KARE STERILE I.V. START KIT is a medical device that received FDA 510(k) clearance on 1984-12-19. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K844255.

When did GENT-L-KARE STERILE I.V. START KIT receive FDA 510(k) clearance?

GENT-L-KARE STERILE I.V. START KIT received FDA 510(k) clearance on 1984-12-19, under 510(k) number K844255.

Who is the listed applicant for GENT-L-KARE STERILE I.V. START KIT?

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

What is the FDA product code for GENT-L-KARE STERILE I.V. START KIT?

The FDA product code for GENT-L-KARE STERILE I.V. START KIT is FPA.

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Other records listing Geneva Laboratories, 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.

K881217GENT-L-KARE STERILE URINARY LEG BAGK881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTERK881218GENT-L-KARE CLEANSING ENEMA SETK881216GENT-L-KARE VAGINAL IRRIGATION SETK861308ACCUPAC CUSTOM PACK KERLIX SQUARESK861219ACCUPAC CUSTOM SKIN SCRUB KIT

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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