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)

CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT

K-Number: K130500 · 2013-07-26

ApplicantSebia
Decision Date2013-07-26
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K130500. The device is classified under product code CEF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT?

CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Sebia. The 510(k) number is K130500.

When did CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT receive FDA 510(k) clearance?

CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT received FDA 510(k) clearance on 2013-07-26, under 510(k) number K130500.

Who is the listed applicant for CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT?

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

What is the FDA product code for CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT?

The FDA product code for CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT is CEF.

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 Sebia 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.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentK231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2K203184HYDRASHIFT 2/4 isatuximabK192095CAPI 3 Immunotyping, Capillarys 3 TeraK190851HYDRASHIFT 2/4 daratumumab

View all 30 devices →

Related Devices (Code: CEF)

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.

K972274SPIFEHelena LaboratoriesK973316REP SPE VIS-60/40 KITHelena LaboratoriesK963018BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESISBio-RadK964453REP 3 FLUR SPE-60 KITHelena LaboratoriesK960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITMoraxK951536HYDRAGEL PROTEIN(E) KITSebia

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.

↑