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)

CYTO-CHEX BCT

K-Number: K080552 · 2008-07-31

ApplicantStreck
Decision Date2008-07-31
Product CodeGIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYTO-CHEX BCT is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2008-07-31 under 510(k) number K080552. 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 CYTO-CHEX BCT?

CYTO-CHEX BCT is a medical device that received FDA 510(k) clearance on 2008-07-31. The listed applicant is Streck. The 510(k) number is K080552.

When did CYTO-CHEX BCT receive FDA 510(k) clearance?

CYTO-CHEX BCT received FDA 510(k) clearance on 2008-07-31, under 510(k) number K080552.

Who is the listed applicant for CYTO-CHEX BCT?

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

What is the FDA product code for CYTO-CHEX BCT?

The FDA product code for CYTO-CHEX BCT is GIM.

Other records listing Streck 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.

K254166MDx-Chex for BCNK231221MDx-Chex for BC-GPK231223MDx-Chex for BC-GNK170091UA-Cellular CompleteK160585XN CALK160590XN CHECK

View all 28 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.K012152DS30 HCY BLOOD COLLECTION TUBESDrew Scientific , Ltd.K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)Becton Dickinson Vacutainer Systems

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.

↑