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FDA 510(k)

CAPILLARYS IMMUNOTYPING, MODEL 2100

K-Number: K082085 · 2009-04-17

ApplicantSebia
Decision Date2009-04-17
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CAPILLARYS IMMUNOTYPING, MODEL 2100 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2009-04-17 under 510(k) number K082085. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPILLARYS IMMUNOTYPING, MODEL 2100?

CAPILLARYS IMMUNOTYPING, MODEL 2100 is a medical device that received FDA 510(k) clearance on 2009-04-17. The listed applicant is Sebia. The 510(k) number is K082085.

When did CAPILLARYS IMMUNOTYPING, MODEL 2100 receive FDA 510(k) clearance?

CAPILLARYS IMMUNOTYPING, MODEL 2100 received FDA 510(k) clearance on 2009-04-17, under 510(k) number K082085.

Who is the listed applicant for CAPILLARYS IMMUNOTYPING, MODEL 2100?

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, MODEL 2100?

The FDA product code for CAPILLARYS IMMUNOTYPING, MODEL 2100 is CFF.

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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

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Related Devices (Code: CFF)

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.

K203184HYDRASHIFT 2/4 isatuximabSebiaK192095CAPI 3 Immunotyping, Capillarys 3 TeraSebiaK190851HYDRASHIFT 2/4 daratumumabSebiaK172195HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebiaK161928CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROLSebiaK120169INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENTGrifols USA, LLC

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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