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510(k) K092817

POC-AS10 AUTO SAMPLER by Otsuka Pharmaceutical Co., Ltd. — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2010
Date Received
September 14, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Urea (Breath Or Blood)
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Otsuka Pharmaceutical Co., Ltd.

  • K052716 — RAPIRUN H. PYLORI ANTIBODY DETECTION KIT (November 16, 2006)
  • K041148 — POCONE INFRARED SPECTROPHOTOMETER (July 15, 2004)
  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K001032 — RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY (July 24, 2000)
  • K991083 — RLP CHOLESTEROL IMMUNOSEPARATION ASSAY (August 20, 1999)

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  • K193610 — BreathID Smart System (February 6, 2020)
  • K173777 — BreathID Hp Lab System (March 8, 2018)
  • K173772 — BreathID Hp System (March 8, 2018)
  • K162150 — BreathID Hp Lab System (October 31, 2016)
  • K130524 — BREATHID HP SYSTEM (May 22, 2013)
  • K093834 — CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (September 29, 2010)
  • K041148 — POCONE INFRARED SPECTROPHOTOMETER (July 15, 2004)