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510(k) K200475

IDS-iSYS Ostase BAP by Immunodiagnostic Systems , Ltd. — Product Code CIN

K200475 is an FDA 510(k) premarket notification submitted by Immunodiagnostic Systems , Ltd. for the device "IDS-iSYS Ostase BAP". The FDA issued a decision of Substantially Equivalent on September 30, 2020. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Immunodiagnostic Systems , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2020
Date Received
February 26, 2020
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 Immunodiagnostic Systems , Ltd.

  • K202136 — IDS Cortisol (April 13, 2021)
  • K190121 — IDS SHBG (June 17, 2019)
  • K161158 — IDS-iSYS Intact PTHN (January 31, 2017)
  • K161831 — IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (November 15, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K142351 — 25-Hydroxy Vitamin Ds EIA (August 25, 2015)
  • K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone (April 21, 2015)
  • K143324 — IDS-iSYS CTX-I Calibration Verifiers (March 30, 2015)
  • K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (December 19, 2014)
  • K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)

Other clearances for product code CIN

  • K232904 — Access Ostase (April 15, 2024)
  • 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)
  • K952768 — ALKPHASE-B ASSAY KIT (August 24, 1995)

FDA data resources