Home / 510(k) Clearances / K994278

510(k) K994278

ACCESS OSTASE IMMUNOENZYMETRIC ASSAY by Beckman Coulter, Inc. — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2000
Date Received
December 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Beckman Coulter, Inc.

  • K254059 — Access anti-HBc IgM (March 13, 2026)
  • K253687 — Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access (February 19, 2026)
  • K251995 — Access anti-HAV IgM (January 27, 2026)
  • K250588 — Access Rubella IgG (November 17, 2025)
  • K252580 — iQ200 Series (September 10, 2025)
  • K243846 — Access anti-HAV (September 9, 2025)
  • K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m (August 20, 2025)
  • K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg (August 15, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/m (July 18, 2025)

Other clearances for product code CIN

  • K232904 — Access Ostase (April 15, 2024)
  • K200475 — IDS-iSYS Ostase BAP (September 30, 2020)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K020625 — SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (May 6, 2002)
  • K011113 — HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PA (June 13, 2001)
  • K981373 — ALKPHASE-B ASSAY KIT (May 27, 1998)
  • K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (September 11, 1997)
  • K964764 — OPUS BONE ALP (January 24, 1997)
  • K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (August 19, 1996)
  • K952768 — ALKPHASE-B ASSAY KIT (August 24, 1995)