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510(k) K832314

CARDIZYME PLUS LD #65094/93 by Em Industries, Inc. — Product Code CFE

K832314 is an FDA 510(k) premarket notification submitted by Em Industries, Inc. for the device "CARDIZYME PLUS LD #65094/93". The FDA issued a decision of Substantially Equivalent on September 1, 1983. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Em Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1983
Date Received
July 14, 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

Other clearances by Em Industries, Inc.

  • K823756 — ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 (January 12, 1983)

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

FDA data resources