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510(k) K882766

EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 by Em Diagnostic Systems, Inc. — Product Code DLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1988
Date Received
July 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Liquid, Glc
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type

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  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

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