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510(k) K962718

FEMEXAM TESTCARD by Litmus Concepts, Inc. — Product Code CEN

K962718 is an FDA 510(k) premarket notification submitted by Litmus Concepts, Inc. for the device "FEMEXAM TESTCARD". The FDA issued a decision of Substantially Equivalent on February 7, 1997. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550. Litmus Concepts, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1997
Date Received
July 12, 1996
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

Other clearances by Litmus Concepts, Inc.

  • K964015 — INDICARD TEST (June 19, 1997)

Other clearances for product code CEN

  • K091287 — VS-SENSE TEST (August 31, 2009)
  • K071100 — AMNISCREEN HOME DETECTION LINER KIT (October 15, 2007)
  • 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)
  • K840827 — KYOTEST 5V (May 14, 1984)
  • K830824 — URINE SCREENING KIT (June 12, 1983)
  • K830979 — HELENA BIOSTRIP PH (May 5, 1983)
  • K830091 — LITH A TEST TM (February 15, 1983)
  • K822241 — FOLATE/B12 DUO-BEAD RADIOASSAY (October 26, 1982)

FDA data resources