Home / 510(k) Clearances / K792584

510(k) K792584

ACA ETHOSURIMIDE TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code DLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1979
Date Received
December 14, 1979
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 E.I. Dupont DE Nemours & Co., Inc.

  • K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (July 24, 1996)
  • K953724 — CRONEX RADIATION THERAPY CASSETTE (September 6, 1995)
  • K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE (September 6, 1995)
  • K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD (June 1, 1995)
  • K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 13, 1995)
  • K950136 — URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (March 30, 1995)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

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)
  • K823801 — AMES TDA ETHOSUXIMIDE TEST (January 14, 1983)
  • K823745 — ADVANCE EMIT-AED ETHOSUXIMIDE (January 7, 1983)
  • K780461 — ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (April 12, 1978)
  • K780380 — ANALYZER, FAST, CENTRIFUGAL, GEMSAEC (April 12, 1978)