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510(k) K860143

URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE by Reagent Laboratory, Inc. — Product Code JJP

K860143 is an FDA 510(k) premarket notification submitted by Reagent Laboratory, Inc. for the device "URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE". The FDA issued a decision of Substantially Equivalent on February 10, 1986. The device falls under product code JJP (Electrode, Ion Selective (Non-Specified)), a Class I device regulated under 21 CFR 862.2050. Reagent Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1986
Date Received
January 15, 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

Other clearances by Reagent Laboratory, Inc.

  • K863502 — SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (October 21, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • K842982 — FORMALIN BUFFERED (October 1, 1984)
  • K843050 — GRAM STAIN (September 11, 1984)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 1984)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K843051 — WRIGHTS STAIN SOLUTION (August 3, 1984)
  • K841800 — LYSING & HEMOGLOBIN REAGENT (May 31, 1984)
  • K841799 — CYANOMETHEMOGLOBIN REAGENT (May 31, 1984)

Other clearances for product code JJP

  • K900280 — CENTRIPREP 100 (February 16, 1990)
  • K863438 — NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER (September 29, 1986)

FDA data resources