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510(k) K030533

ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST by Cenogenics Corp. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2003
Date Received
February 14, 2003
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 Cenogenics Corp.

  • K042641 — CHEMVIEW-10 (January 7, 2005)
  • K992397 — ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE (August 26, 1999)
  • K894793 — MONODEX (August 21, 1989)
  • K843680 — URI-VAL (March 29, 1985)

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