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510(k) K863486

POTASSIUM TEST by Sclavo, Inc. — Product Code CEJ

K863486 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "POTASSIUM TEST". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code CEJ (Tetraphenyl Borate, Colorimetry, Potassium), a Class II device regulated under 21 CFR 862.1600. Sclavo, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 9, 1986
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

Other clearances by Sclavo, Inc.

  • K914789 — ELISA CMV IGM (March 4, 1992)
  • K914852 — ELISA TOXO IGM (January 23, 1992)
  • K914420 — ELISA RUBELLA IGM (December 27, 1991)
  • K895943 — NORMAL AND ABNORMAL CONTROL SERA (December 27, 1989)
  • K895822 — TOTAL BILIRUBIN L.F. (November 14, 1989)
  • K895847 — CREATININE 340 (ENZYMATIC) (October 30, 1989)
  • K880049 — CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K873496 — ATYPICAL CHOLINESTERASE (January 27, 1989)
  • K880199 — CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K884035 — SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (December 29, 1988)

Other clearances for product code CEJ

  • K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (February 10, 2005)
  • K943026 — POTASSIUM QVET (December 9, 1994)
  • K904033 — REFLOTRON POTASSIUM TEST TABS (November 6, 1990)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K883586 — TECHNICON RA-100 SYSTEM POTASSIUM (November 29, 1988)
  • K883585 — TECHNICON ASSIST POTASSIUM (November 29, 1988)
  • K881440 — IQ POTASSIUM (May 27, 1988)
  • K880339 — EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (February 25, 1988)
  • K861713 — SERUM POTASSIUM REAGENT SET (May 23, 1986)
  • K853404 — QCA POTASSIUM TEST KIT (August 23, 1985)

FDA data resources