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510(k) K823801

AMES TDA ETHOSUXIMIDE TEST by Miles Laboratories, Inc. — Product Code DLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 17, 1982
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

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  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

Other clearances for product code DLF

  • K881607 — EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 (June 1, 1988)
  • K850174 — TDX ETHOSUXIMIDE (February 6, 1985)
  • K844204 — EMIT QST ETHOSUXIMIDE ASSAY (December 11, 1984)
  • K832797 — MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY (September 29, 1983)
  • K823745 — ADVANCE EMIT-AED ETHOSUXIMIDE (January 7, 1983)
  • K792584 — ACA ETHOSURIMIDE TEST PACK (December 31, 1979)
  • K780461 — ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (April 12, 1978)
  • K780380 — ANALYZER, FAST, CENTRIFUGAL, GEMSAEC (April 12, 1978)