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510(k) K912386

REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 by Helena Laboratories — Product Code CEF

K912386 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165". The FDA issued a decision of Substantially Equivalent on July 17, 1991. The device falls under product code CEF (Electrophoretic, Protein Fractionation), a Class I device regulated under 21 CFR 862.1630. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
April 26, 1991
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 Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

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)
  • 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)

FDA data resources