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510(k) K992397

ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE by Cenogenics Corp. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1999
Date Received
July 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Cenogenics Corp.

  • K042641 — CHEMVIEW-10 (January 7, 2005)
  • K030533 — ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PRE (April 17, 2003)
  • K894793 — MONODEX (August 21, 1989)
  • K843680 — URI-VAL (March 29, 1985)

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  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)