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510(k) K972274

Device
SPIFE
Applicant
HELENA LABORATORIES
510(k) number
K972274
Product code
CEF  
Decision
Substantially Equivalent (SESE)
Decision date
1997-10-27
Date received
1997-06-18
Regulation
862.1630
Classification name
Electrophoretic, Protein Fractionation
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAT FRANKS
Address
1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CEF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130500CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTSebia2013-07-26
K973316REP SPE VIS-60/40 KITHelena Laboratories1997-10-01
K963018BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESISBio-Rad1997-06-04
K964453REP 3 FLUR SPE-60 KITHelena Laboratories1996-12-23
K960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITMorax1996-07-17
K951536HYDRAGEL PROTEIN(E) KITSebia1995-06-30
K930317REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278Helena Laboratories1993-08-03
K922053REP SPE PLUS (PONCEAU S) SYSTEMHelena Laboratories1992-08-18
K922024REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175Helena Laboratories1992-07-23
K913315BIO-RAD TOTAL PROTEIN TEST KITBio-Rad1992-01-02
K913807REP(R) SPE TEMPLATE 30, 16, & 8Helena Laboratories1991-11-27
K913058REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172Helena Laboratories1991-10-30
K912386REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165Helena Laboratories1991-07-17
K911468REP SPE PLUS (ACID BLUE) SYSTEMHelena Laboratories1991-04-16
K900251REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175Helena Laboratories1990-02-26

Legacy Summary#

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FDA Review#

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