Home / 510(k) Clearances / K862671

510(k) K862671

MICROALBUMINURIA ASSAY by Orion Corp. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1986
Date Received
July 14, 1986
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

Other clearances by Orion Corp.

  • K912391 — RUBALEX, MODIFICATION (May 4, 1992)
  • K901637 — RESUBMITTED MODIFIED RUBALEX (April 26, 1990)
  • K884650 — RESUBMITTED SCANORA (March 16, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K881506 — MAMEX DC MAG MG12 (June 10, 1988)
  • K881505 — MAMEX DC MG11 (June 10, 1988)
  • K874040 — MAMEX DC S SL10/MG14 (November 23, 1987)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K864457 — CHLAMYSET ANTIBODY EIA (September 11, 1987)
  • K872301 — DENTOCULT-SM CULTURE-PADDLE (September 11, 1987)

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)
  • K100853 — COBAS 8000 MODULAR SERIES ANALYZER (September 9, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K082251 — SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (April 8, 2009)