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FDA 510(k)

CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE

K-Number: K872795 · 1987-09-04

ApplicantMedex, Inc.
Decision Date1987-09-04
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K872795. 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 CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE?

CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Medex, Inc.. The 510(k) number is K872795.

When did CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE receive FDA 510(k) clearance?

CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE received FDA 510(k) clearance on 1987-09-04, under 510(k) number K872795.

Who is the listed applicant for CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE?

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

What is the FDA product code for CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE?

The FDA product code for CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE is FPA.

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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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