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FDA 510(k)

BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS

K-Number: K963018 · 1997-06-04

ApplicantBio-Rad
Decision Date1997-06-04
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1997-06-04 under 510(k) number K963018. 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 BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS?

BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS is a medical device that received FDA 510(k) clearance on 1997-06-04. The listed applicant is Bio-Rad. The 510(k) number is K963018.

When did BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS receive FDA 510(k) clearance?

BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS received FDA 510(k) clearance on 1997-06-04, under 510(k) number K963018.

Who is the listed applicant for BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS?

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

What is the FDA product code for BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS?

The FDA product code for BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS is CEF.

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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.

K130500CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTSebiaK972274SPIFEHelena LaboratoriesK973316REP SPE VIS-60/40 KITHelena LaboratoriesK964453REP 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.

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