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510(k) K854732

API 50 CHB (CULTURE MEDIA) by Dms Products, Inc. — Product Code JST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
November 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Fastidious Organisms
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)
  • K890625 — JAMES REAGENT (February 17, 1989)
  • K854733 — API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) (March 6, 1986)

Other clearances for product code JST

  • K962423 — BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM (August 2, 1996)
  • K841661 — SYNTHETIC BROTH A.O.A.C. (May 11, 1984)
  • K832239 — RIM-HAEMOPHILUS 2 (August 12, 1983)
  • K832051 — RIM-HAEMOPHILUS 1 & 2 (August 12, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)