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510(k) K132664

ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR by Siemens Healthcare Diagnostics, Inc. — Product Code CJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2013
Date Received
August 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Purple Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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Other clearances for product code CJW

  • K203530 — Albumin BCP2 (March 18, 2022)
  • K193001 — Albumin BCP (December 19, 2019)
  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K000483 — RANDOX ALBUMIN (March 31, 2000)
  • K990978 — ALBUMIN BCG, MODEL AL 103-01 (May 25, 1999)
  • K981814 — ALBP (July 22, 1998)
  • K981457 — ALBP (May 27, 1998)
  • K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (October 9, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)
  • K863226 — ALBUMIN (BCP) (September 17, 1986)