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510(k) K890625

JAMES REAGENT by Dms Products, Inc. — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
February 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Dms Products, Inc.

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  • K894805 — RAPIDEC UR (September 26, 1989)
  • K890626 — RAPIDEC COLI (June 2, 1989)
  • K854733 — API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) (March 6, 1986)
  • K854732 — API 50 CHB (CULTURE MEDIA) (March 4, 1986)

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  • K960996 — M. CAT BUTYRATE DISK (April 18, 1996)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)