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510(k) K013371

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM by Otsuka Pharmaceutical Co., Ltd. — Product Code JJQ

K013371 is an FDA 510(k) premarket notification submitted by Otsuka Pharmaceutical Co., Ltd. for the device "UBIT-IR300 INFRARED SPECTROMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 2001. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Otsuka Pharmaceutical Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2001
Date Received
October 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

Other clearances by Otsuka Pharmaceutical Co., Ltd.

  • K092817 — POC-AS10 AUTO SAMPLER (March 9, 2010)
  • K052716 — RAPIRUN H. PYLORI ANTIBODY DETECTION KIT (November 16, 2006)
  • K041148 — POCONE INFRARED SPECTROPHOTOMETER (July 15, 2004)
  • K001032 — RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY (July 24, 2000)
  • K991083 — RLP CHOLESTEROL IMMUNOSEPARATION ASSAY (August 20, 1999)

Other clearances for product code JJQ

  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (February 4, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)
  • K953005 — BILI-METER (September 28, 1995)

FDA data resources