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510(k) K130500

CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT by Sebia — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2013
Date Received
February 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
Review Panel
CH
Submission Type

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Other clearances for product code CEF

  • K972274 — SPIFE (October 27, 1997)
  • K973316 — REP SPE VIS-60/40 KIT (October 1, 1997)
  • K963018 — BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (June 4, 1997)
  • K964453 — REP 3 FLUR SPE-60 KIT (December 23, 1996)
  • K960029 — HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (July 17, 1996)
  • K951536 — HYDRAGEL PROTEIN(E) KIT (June 30, 1995)
  • K930317 — REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (August 3, 1993)
  • K922053 — REP SPE PLUS (PONCEAU S) SYSTEM (August 18, 1992)
  • K922024 — REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (July 23, 1992)
  • K913315 — BIO-RAD TOTAL PROTEIN TEST KIT (January 2, 1992)