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510(k) K832797

MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY by Syva Co. — Product Code DLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 18, 1983
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 Syva Co.

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  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)
  • K993982 — SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL (January 27, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)

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)
  • 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)