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510(k) K882766

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

K882766 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95". The FDA issued a decision of Substantially Equivalent on August 23, 1988. The device falls under product code DLG (Coating, Liquid, Glc), a Class I device regulated under 21 CFR 862.2250. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code DLG

  • K050988 — OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (April 6, 2006)
  • K920419 — IL TEST DAT CAL/CONTROL SET D/E (March 11, 1992)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (September 25, 1989)
  • K833385 — N-ACETYLPROCAINAMIDE CALIBRATOR (December 16, 1983)

FDA data resources