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510(k) K813608

POTASSIUM REAGENT SET by Diagnostic Specialties — Product Code CEJ

K813608 is an FDA 510(k) premarket notification submitted by Diagnostic Specialties for the device "POTASSIUM REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code CEJ (Tetraphenyl Borate, Colorimetry, Potassium), a Class II device regulated under 21 CFR 862.1600. Diagnostic Specialties has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
December 29, 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

Other clearances by Diagnostic Specialties

  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K930823 — PROTEIN-BOUND GLUCOSE ASSAYN KIT (August 19, 1993)
  • K922032 — ENZIP URINARY MICROALBUMIN TEST (July 30, 1992)
  • K831180 — PREGNA-CERT, SLIDE PREGNANCY TEST (May 27, 1983)
  • K823109 — GENERIC PREGNANCY TEST (November 10, 1982)
  • K813412 — GLUCOSE ENZYME-COLOR REAGENT SET (December 31, 1981)

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)
  • K883585 — TECHNICON ASSIST POTASSIUM (November 29, 1988)
  • K883586 — TECHNICON RA-100 SYSTEM POTASSIUM (November 29, 1988)
  • K881440 — IQ POTASSIUM (May 27, 1988)
  • 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)

FDA data resources