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510(k) K991369

ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY by Germaine Laboratories, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1999
Date Received
April 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
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)
  • K013857 — AIMSTEP PREGNANCY (January 22, 2002)
  • 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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