Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT

K-Number: K933939 · 1994-02-07

ApplicantOrganon Teknika Corp.
Decision Date1994-02-07
Product CodeGIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1994-02-07 under 510(k) number K933939. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT?

BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT is a medical device that received FDA 510(k) clearance on 1994-02-07. The listed applicant is Organon Teknika Corp.. The 510(k) number is K933939.

When did BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT receive FDA 510(k) clearance?

BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT received FDA 510(k) clearance on 1994-02-07, under 510(k) number K933939.

Who is the listed applicant for BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT?

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

What is the FDA product code for BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT?

The FDA product code for BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT is GIM.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

View all 130 devices →

Related Devices (Code: GIM)

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.

K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and CompanyK230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and CompanyK213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton, Dickinson and CompanyK162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd.K080552CYTO-CHEX BCTStreckK012152DS30 HCY BLOOD COLLECTION TUBESDrew Scientific , Ltd.

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.

↑