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510(k) K885024

ALKALINE PHOSPHATASE ISOENZYME SYSTEM by Ciba Corning Diagnostics Corp. — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
December 5, 1988
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 Ciba Corning Diagnostics Corp.

  • K962559 — ACS CORTISOL IMMUNOASSAY (November 5, 1996)
  • K963251 — CIBA CORNING ACS;180 DPD ASSAY (October 15, 1996)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K961657 — CIBA CORNING 400 SYSTEM (June 25, 1996)
  • K962021 — CIBA CORNING 348 SYSTEM (June 24, 1996)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K962041 — ACS LH2 IMMUNOASSAY (June 21, 1996)
  • K961510 — ACS FRT4 IMMUNOASSAY (June 17, 1996)
  • K960246 — LIQUID CARDIAC MARKER 1,2,3 ASSAYED (April 23, 1996)
  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)

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)
  • K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (March 28, 2000)
  • 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)