Home / 510(k) Clearances / K100853

510(k) K100853

COBAS 8000 MODULAR SERIES ANALYZER by Roche Diagnostics Corp. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2010
Date Received
March 26, 2010
Clearance Type
Special
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

Other clearances by Roche Diagnostics Corp.

  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)
  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K252163 — Elecsys Phospho-Tau (181P) Plasma (October 8, 2025)
  • K242505 — Elecsys Cortisol III (July 17, 2025)
  • K250768 — Elecsys Anti-SARS-CoV-2 (June 10, 2025)
  • K241453 — Elecsys sFlt-1 and Elecsys PlGF (February 7, 2025)
  • K233060 — Elecsys Folate III (June 17, 2024)
  • K220272 — cobas pulse blood glucose monitoring system (April 26, 2024)

Other clearances for product code DCF

  • K153560 — Optilite Low Level Albumin Kit (August 25, 2016)
  • K143118 — Human Microalbumin kit for use on SPAPLUS (May 26, 2015)
  • K142346 — Urine/CSF Albumin, Urine/CSF Albumin Calibrator (October 15, 2014)
  • K121045 — HUMAN ALBUMIN CSF KIT (June 19, 2013)
  • K113072 — TINA-QUANT ALBUMIN GEN.2 (May 14, 2012)
  • K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (July 13, 2011)
  • K101203 — TINA-QUANT ALBUMIN GEN 2 (September 10, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (April 8, 2009)
  • K061990 — DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTE (September 19, 2006)