Home / 510(k) Clearances / K922953

510(k) K922953

SYSTEMATE CALCIUM TEST TECHNICON RA 1000 by Em Diagnostic Systems, Inc. — Product Code CIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1992
Date Received
June 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresol Red Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
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)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code CIL

  • K895880 — PANCREATIC A-AMYLASE EPS (December 19, 1989)
  • K833724 — ENZYMATIC CO2 (December 29, 1983)
  • K800111 — CO2 CONTENT (February 13, 1980)