Home / 510(k) Clearances / K951536

510(k) K951536

HYDRAGEL PROTEIN(E) KIT by Sebia — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1995
Date Received
April 3, 1995
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

Other clearances by Sebia

  • K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (April 4, 2024)
  • K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (February 23, 2024)
  • K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (November 18, 2022)
  • K203184 — HYDRASHIFT 2/4 isatuximab (November 12, 2021)
  • K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera (November 1, 2019)
  • K190851 — HYDRASHIFT 2/4 daratumumab (May 2, 2019)
  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171861 — CAPILLARYS Hb A1c (February 7, 2018)
  • K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control (January 11, 2018)
  • K171537 — CAPI 3 Hb A1c (September 12, 2017)

Other clearances for product code CEF

  • K130500 — CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FL (July 26, 2013)
  • 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)
  • 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)