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510(k) K892818

REP(TM) LD-2 STAT KIT, CAT. NO. 3078 by Helena Laboratories — Product Code CFE

K892818 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "REP(TM) LD-2 STAT KIT, CAT. NO. 3078". The FDA issued a decision of Substantially Equivalent on June 20, 1989. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1989
Date Received
April 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
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 CFE

  • K100307 — GELSCAN, MODEL 1206 (August 31, 2010)
  • K022455 — SPIFE LD-12 KIT, MODEL 3338 (October 1, 2002)
  • K020467 — SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (March 29, 2002)
  • K970477 — HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (March 10, 1997)
  • K940224 — CARDIO REP LD (August 17, 1994)
  • K921455 — ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (April 29, 1992)
  • K905861 — ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH (February 6, 1991)
  • K894081 — ROCHO ISOMUNE - LD (August 31, 1989)
  • K874142 — TITAN GEL REP LDH-30 HV (November 24, 1987)
  • K874145 — TITAN GEL REP LDH-6 HV (November 24, 1987)

FDA data resources