Home / 510(k) Clearances / K013249

510(k) K013249

TINA-QUANT APOLIPOPROTEIN VER.2 by Roche Diagnostics Corp. — Product Code DER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2001
Date Received
September 28, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5580
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 DER

  • K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3 (May 18, 2000)
  • K993354 — K-ASSAY APO B (October 28, 1999)
  • K993345 — K-ASSAY APO AI (October 25, 1999)
  • K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (April 14, 1999)
  • K983289 — APOLIPOPROTEIN A1 (January 29, 1999)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K910553 — ROCHE APOLIPOPROTEIN STANDARD (May 8, 1991)
  • K904125 — UC IMU A (September 24, 1990)