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)

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

K-Number: K013401 · 2001-12-14

ApplicantK-Systems, Kivex Biotec , Ltd.
Decision Date2001-12-14
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 is the device name listed in this FDA 510(k) record. The listed applicant is K-Systems, Kivex Biotec , Ltd.. It received FDA 510(k) clearance on 2001-12-14 under 510(k) number K013401. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01?

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is K-Systems, Kivex Biotec , Ltd.. The 510(k) number is K013401.

When did K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 receive FDA 510(k) clearance?

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 received FDA 510(k) clearance on 2001-12-14, under 510(k) number K013401.

Who is the listed applicant for K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01?

The FDA 510(k) record lists K-Systems, Kivex Biotec , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01?

The FDA product code for K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 is MQG.

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

Related Devices (Code: MQG)

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.

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)CooperSurgical, Inc.K260194Vacuum Pump (Model: AD-VPUM-500)Sheng Sheng Yi (Beijing) Technology Company LimitedK242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd.K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.K173264EmbryoScope+Vitrolife A/S

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.

↑