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510(k) K914261

ABBOTT QUICKSTART LD-1,#5A30 by Em Diagnostic Systems, Inc. — Product Code JGF

K914261 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "ABBOTT QUICKSTART LD-1,#5A30". The FDA issued a decision of Substantially Equivalent on October 21, 1991. The device falls under product code JGF (Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1991
Date Received
September 23, 1991
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 Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code JGF

  • K981338 — LD-1 (May 18, 1998)
  • K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION (February 5, 1993)
  • K890996 — LD1 ISOENZYME REAGENT KIT (May 5, 1989)
  • K871240 — ABBOTT A-GENT LD-1 ISOZYME REAGENT (May 13, 1987)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)

FDA data resources