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510(k) K830872

TITAN GEL LDH ISO-ENZYME CONTROL by Helena Laboratories — Product Code CFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
March 18, 1983
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

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  • 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)
  • K892818 — REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (June 20, 1989)
  • K874145 — TITAN GEL REP LDH-6 HV (November 24, 1987)