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510(k) K812677

UNITEST-POTASSIUM by Biodynamics Corp. — Product Code CEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
September 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetraphenyl Borate, Colorimetry, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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Other clearances for product code CEJ

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  • K883586 — TECHNICON RA-100 SYSTEM POTASSIUM (November 29, 1988)
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  • K880339 — EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (February 25, 1988)
  • K863486 — POTASSIUM TEST (September 29, 1986)
  • K861713 — SERUM POTASSIUM REAGENT SET (May 23, 1986)