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FDA 510(k)

CAPILLARYS URINE

K-Number: K080916 · 2008-07-01

ApplicantSebia
Decision Date2008-07-01
Product CodeJKM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CAPILLARYS URINE is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2008-07-01 under 510(k) number K080916. The device is classified under product code JKM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPILLARYS URINE?

CAPILLARYS URINE is a medical device that received FDA 510(k) clearance on 2008-07-01. The listed applicant is Sebia. The 510(k) number is K080916.

When did CAPILLARYS URINE receive FDA 510(k) clearance?

CAPILLARYS URINE received FDA 510(k) clearance on 2008-07-01, under 510(k) number K080916.

Who is the listed applicant for CAPILLARYS URINE?

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 URINE?

The FDA product code for CAPILLARYS URINE is JKM.

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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: JKM)

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.

K070486CAPILLARYS URINE (PN 2012)Sebia, Inc.K050119PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KITBeckman Coulter, Inc.K972591HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KITMorax

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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