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510(k) K862403

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 by Diagnostic Systems — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1986
Date Received
June 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (March 15, 1988)
  • K854784 — ABSORBANCE (ABS) TEST PAK (December 19, 1985)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (September 25, 1985)
  • K853532 — ALCOHOL CALIBRATORS (September 16, 1985)

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