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510(k) K830091

LITH A TEST TM by Lenal Creative Approaches, Inc. — Product Code CEN

K830091 is an FDA 510(k) premarket notification submitted by Lenal Creative Approaches, Inc. for the device "LITH A TEST TM". The FDA issued a decision of Substantially Equivalent on February 15, 1983. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

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  • K051727 — AIMSTICK URINE REAGENT STRIPS (October 26, 2005)
  • K040008 — QUICKVUE ADVANCE PH AND AMINES GLL TEST (April 29, 2004)
  • K030650 — STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (April 14, 2003)
  • K962718 — FEMEXAM TESTCARD (February 7, 1997)
  • K840827 — KYOTEST 5V (May 14, 1984)
  • K830824 — URINE SCREENING KIT (June 12, 1983)
  • K830979 — HELENA BIOSTRIP PH (May 5, 1983)
  • K822241 — FOLATE/B12 DUO-BEAD RADIOASSAY (October 26, 1982)

FDA data resources