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510(k) K881607

EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 by Em Diagnostic Systems, Inc. — Product Code DLF

K881607 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code DLF (Enzyme Immunoassay, Ethosuximide), a Class II device regulated under 21 CFR 862.3380. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1988
Date Received
April 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Ethosuximide
Device Class
Class II
Regulation Number
862.3380
Review Panel
TX
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 DLF

  • K850174 — TDX ETHOSUXIMIDE (February 6, 1985)
  • K844204 — EMIT QST ETHOSUXIMIDE ASSAY (December 11, 1984)
  • K832797 — MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY (September 29, 1983)
  • K823801 — AMES TDA ETHOSUXIMIDE TEST (January 14, 1983)
  • K823745 — ADVANCE EMIT-AED ETHOSUXIMIDE (January 7, 1983)
  • K792584 — ACA ETHOSURIMIDE TEST PACK (December 31, 1979)
  • K780380 — ANALYZER, FAST, CENTRIFUGAL, GEMSAEC (April 12, 1978)
  • K780461 — ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (April 12, 1978)

FDA data resources