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FDA 510(k)

PROVIDER SITE PREP & CHECK STRIP KIT

K-Number: K841027 · 1984-04-16

ApplicantPancretec, Inc.
Decision Date1984-04-16
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROVIDER SITE PREP & CHECK STRIP KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pancretec, Inc.. It received FDA 510(k) clearance on 1984-04-16 under 510(k) number K841027. 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 PROVIDER SITE PREP & CHECK STRIP KIT?

PROVIDER SITE PREP & CHECK STRIP KIT is a medical device that received FDA 510(k) clearance on 1984-04-16. The listed applicant is Pancretec, Inc.. The 510(k) number is K841027.

When did PROVIDER SITE PREP & CHECK STRIP KIT receive FDA 510(k) clearance?

PROVIDER SITE PREP & CHECK STRIP KIT received FDA 510(k) clearance on 1984-04-16, under 510(k) number K841027.

Who is the listed applicant for PROVIDER SITE PREP & CHECK STRIP KIT?

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

What is the FDA product code for PROVIDER SITE PREP & CHECK STRIP KIT?

The FDA product code for PROVIDER SITE PREP & CHECK STRIP KIT is FPA.

Related Clinical Trials

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.

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Other records listing Pancretec, 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.

K882102PROVIDER ONE INFUSION SYSTEMK871806PROVIDER IV. MODEL 5000 INFUSION DEVICEK844078PROVIDER PA 3000 INFUSION SYSTEMK843463PROVIDER BAG SPIKE W/12 MICROBORE EXTENK841373PROVIDER IV MODEL 2000 INFUSIN SYSK841017PROVIDER INFUSION SET

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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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