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510(k) K873426

EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 by Em Diagnostic Systems, Inc. — Product Code KLP

K873426 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645". The FDA issued a decision of Substantially Equivalent on October 29, 1987. The device falls under product code KLP (Amikacin Serum Assay), a Class II device regulated under 21 CFR 862.3035. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1987
Date Received
August 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amikacin Serum Assay
Device Class
Class II
Regulation Number
862.3035
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 KLP

  • K032279 — ONLINE TDM AMIKA (October 10, 2003)
  • K790899 — BACTEC (May 23, 1979)
  • K780949 — BIO-MONITOR AMIKACIN (August 14, 1978)

FDA data resources