Home / 510(k) Clearances / K960029

510(k) K960029

HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT by Morax — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1996
Date Received
January 2, 1996
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 Morax

  • K033277 — HYDRAGEL CSF ISOFOCUSING KITS (November 4, 2003)
  • K012789 — MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (January 17, 2002)
  • K992148 — HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL I (December 29, 1999)
  • K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), A (June 21, 1999)
  • K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P (June 18, 1999)
  • K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI (October 7, 1998)
  • K981048 — HYDRAGEL 6 CSF KIT (October 7, 1998)
  • K972591 — HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES (March 4, 1998)
  • K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT (October 27, 1997)
  • K963844 — HYDRAGEL 15 HB A1C KIT (April 22, 1997)

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)
  • 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)