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510(k) K013857

AIMSTEP PREGNANCY by Germaine Laboratories, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2002
Date Received
November 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Germaine Laboratories, Inc.

  • K051727 — AIMSTICK URINE REAGENT STRIPS (October 26, 2005)
  • 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)

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