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510(k) K890625

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

K890625 is an FDA 510(k) premarket notification submitted by Dms Products, Inc. for the device "JAMES REAGENT". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Dms Products, Inc. has at least 5 other 510(k) clearances on record.

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.

  • K891004 — RAPIDEC STAPH (November 9, 1989)
  • 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)

Other clearances for product code JTO

  • K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (September 1, 2005)
  • K970832 — PYR SWAB (April 24, 1997)
  • K970834 — GRAM SWAB (April 17, 1997)
  • K970833 — INDOLE SWAB (April 2, 1997)
  • K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (February 6, 1997)
  • K962966 — IDS RAPID CB PLUS SYSTEM (October 8, 1996)
  • K961191 — COLISCREEN (June 17, 1996)
  • K960996 — M. CAT BUTYRATE DISK (April 18, 1996)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)

FDA data resources