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510(k) K070207

MULTI-ANALYTE CHEMISTRY CALIBRATOR by Pointe Scientific, Inc., — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2007
Date Received
January 22, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Pointe Scientific, Inc.,

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  • K062118 — POINTE 360 (July 13, 2007)
  • K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT (April 30, 2007)
  • K070504 — AMMONIA/ALCOHOL CONTROL SET (April 11, 2007)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (March 28, 2007)
  • K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (October 7, 2005)
  • K040391 — TOTAL BILIRUBIN REAGENT SET (June 2, 2004)
  • K031539 — HEMOGLOBIN A1C REAGENT SET (August 6, 2003)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)
  • K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (March 31, 2003)

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