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510(k) K051191

DCL MICROALBUMIN ASSAY, MODEL 252-20 by Diagnostic Chemicals , Ltd. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2005
Date Received
May 10, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

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  • K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299- (December 27, 2004)
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  • K041926 — HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 (November 23, 2004)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)

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  • K121045 — HUMAN ALBUMIN CSF KIT (June 19, 2013)
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  • K100853 — COBAS 8000 MODULAR SERIES ANALYZER (September 9, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
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