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510(k) K033277

HYDRAGEL CSF ISOFOCUSING KITS by Morax — Product Code CFF

K033277 is an FDA 510(k) premarket notification submitted by Morax for the device "HYDRAGEL CSF ISOFOCUSING KITS". The FDA issued a decision of Substantially Equivalent on November 4, 2003. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Morax has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2003
Date Received
October 10, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Morax

  • 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)
  • K981048 — HYDRAGEL 6 CSF KIT (October 7, 1998)
  • K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI (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)
  • K960029 — HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (July 17, 1996)

Other clearances for product code CFF

  • 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)
  • K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control (January 11, 2018)
  • K161928 — CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL (December 21, 2016)
  • K143483 — MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (January 8, 2015)
  • K120169 — INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT (August 24, 2012)
  • K111369 — THE HELENA V8 IMMUNODISPLACEMENT KIT (June 26, 2012)
  • K103757 — IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT (October 13, 2011)
  • K082085 — CAPILLARYS IMMUNOTYPING, MODEL 2100 (April 17, 2009)

FDA data resources