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510(k) K863438

NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER by Nova Biomedical Corp. — Product Code JJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Selective (Non-Specified)
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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  • K041016 — NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (May 7, 2004)

Other clearances for product code JJP

  • K900280 — CENTRIPREP 100 (February 16, 1990)
  • K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (February 10, 1986)