510(k) K130500

Device: CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
Applicant: SEBIA
510(k) number: K130500
Product code: CEF
Decision: Substantially Equivalent (SESE)
Decision date: 2013-07-26
Date received: 2013-02-26
Regulation: 862.1630
Classification name: Electrophoretic, Protein Fractionation
Medical specialty: Clinical Chemistry
Review panel: Immunology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K972274	SPIFE	Helena Laboratories	1997-10-27
K973316	REP SPE VIS-60/40 KIT	Helena Laboratories	1997-10-01
K963018	BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS	Bio-Rad	1997-06-04
K964453	REP 3 FLUR SPE-60 KIT	Helena Laboratories	1996-12-23
K960029	HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT	Morax	1996-07-17
K951536	HYDRAGEL PROTEIN(E) KIT	Sebia	1995-06-30
K930317	REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278	Helena Laboratories	1993-08-03
K922053	REP SPE PLUS (PONCEAU S) SYSTEM	Helena Laboratories	1992-08-18
K922024	REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175	Helena Laboratories	1992-07-23
K913315	BIO-RAD TOTAL PROTEIN TEST KIT	Bio-Rad	1992-01-02
K913807	REP(R) SPE TEMPLATE 30, 16, & 8	Helena Laboratories	1991-11-27
K913058	REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172	Helena Laboratories	1991-10-30
K912386	REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165	Helena Laboratories	1991-07-17
K911468	REP SPE PLUS (ACID BLUE) SYSTEM	Helena Laboratories	1991-04-16
K900251	REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175	Helena Laboratories	1990-02-26

summary

Decision Summary