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510(k) K890996

LD1 ISOENZYME REAGENT KIT by Trace Scientific , Ltd. — Product Code JGF

K890996 is an FDA 510(k) premarket notification submitted by Trace Scientific , Ltd. for the device "LD1 ISOENZYME REAGENT KIT". The FDA issued a decision of Substantially Equivalent on May 5, 1989. The device falls under product code JGF (Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Trace Scientific , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1989
Date Received
February 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
Submission Type

Other clearances by Trace Scientific , Ltd.

  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K981123 — UREA (April 24, 1998)
  • K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (September 27, 1996)
  • K961114 — AST INCORPORATING DST (May 23, 1996)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)
  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)

Other clearances for product code JGF

  • K981338 — LD-1 (May 18, 1998)
  • K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION (February 5, 1993)
  • K914261 — ABBOTT QUICKSTART LD-1,#5A30 (October 21, 1991)
  • K871240 — ABBOTT A-GENT LD-1 ISOZYME REAGENT (May 13, 1987)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)

FDA data resources