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510(k) K041148

POCONE INFRARED SPECTROPHOTOMETER by Otsuka Pharmaceutical Co., Ltd. — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2004
Date Received
May 3, 2004
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.

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  • 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)
  • K092817 — POC-AS10 AUTO SAMPLER (March 9, 2010)