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510(k) K051727

AIMSTICK URINE REAGENT STRIPS by Germaine Laboratories, Inc. — Product Code CEN

K051727 is an FDA 510(k) premarket notification submitted by Germaine Laboratories, Inc. for the device "AIMSTICK URINE REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on October 26, 2005. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550. Germaine Laboratories, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2005
Date Received
June 28, 2005
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 Germaine Laboratories, Inc.

  • K013857 — AIMSTEP PREGNANCY (January 22, 2002)
  • K991369 — ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY (May 10, 1999)
  • K981165 — AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST (April 16, 1998)
  • K980531 — AIMSTEP PREGNANCY (March 6, 1998)
  • K974512 — AIMSTICK PBD COMBO PREGNANCY (January 2, 1998)
  • K974368 — AIMSTICK PBD PREGNANCY (January 2, 1998)
  • K973825 — MIDSTREAM HOME REGNANCY TEST (December 19, 1997)

Other clearances for product code CEN

  • K091287 — VS-SENSE TEST (August 31, 2009)
  • K071100 — AMNISCREEN HOME DETECTION LINER KIT (October 15, 2007)
  • 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)
  • K830091 — LITH A TEST TM (February 15, 1983)
  • K822241 — FOLATE/B12 DUO-BEAD RADIOASSAY (October 26, 1982)

FDA data resources