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510(k) K850174

TDX ETHOSUXIMIDE by Abbott Laboratories — Product Code DLF

K850174 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX ETHOSUXIMIDE". The FDA issued a decision of Substantially Equivalent on February 6, 1985. The device falls under product code DLF (Enzyme Immunoassay, Ethosuximide), a Class II device regulated under 21 CFR 862.3380. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1985
Date Received
January 17, 1985
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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Other clearances for product code DLF

  • K881607 — EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 (June 1, 1988)
  • 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