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510(k) K954995

QUIX RAPID CHOLERA STRIP TEST by Guardian Scientific, Corp. — Product Code GSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1996
Date Received
October 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Vibrio Cholerae, All Varieties
Device Class
Class II
Regulation Number
866.3930
Review Panel
MI
Submission Type

Other clearances by Guardian Scientific, Corp.

  • K972156 — QUIX RAPID E. COLI O157 STRIP TEST (October 16, 1997)
  • K954994 — TRUST (October 18, 1996)
  • K954993 — QUIX RAPID PREGNANCY STRIP TEST (December 13, 1995)

Other clearances for product code GSQ

  • K932622 — CHOLERA SMART(TM) (June 27, 1995)
  • K922432 — CHOLERASCREEN (December 7, 1992)