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510(k) K013178

DC-UIBC-CO2-CAL, MODEL SE-153 by Diagnostic Chemicals , Ltd. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2001
Date Received
September 24, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (November 10, 2005)
  • K051191 — DCL MICROALBUMIN ASSAY, MODEL 252-20 (July 5, 2005)
  • K042330 — ACETAMINOPHEN-SL ASSAY (January 7, 2005)
  • K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299- (December 27, 2004)
  • K042329 — SALICYLATE-SL ASSAY (December 27, 2004)
  • K041926 — HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (November 23, 2004)

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