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510(k) K043125

ORION DIAGNOSTICA UNIQ PINP RIA by Orion Diagnostica, OY — Product Code CIN

K043125 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, OY for the device "ORION DIAGNOSTICA UNIQ PINP RIA". The FDA issued a decision of Substantially Equivalent on May 4, 2005. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Orion Diagnostica, OY has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2005
Date Received
November 12, 2004
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 Orion Diagnostica, OY

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884040 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A (October 19, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

Other clearances for product code CIN

  • K232904 — Access Ostase (April 15, 2024)
  • K200475 — IDS-iSYS Ostase BAP (September 30, 2020)
  • 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)
  • K952768 — ALKPHASE-B ASSAY KIT (August 24, 1995)

FDA data resources