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510(k) K854733

API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) by Dms Products, Inc. — Product Code JSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1986
Date Received
November 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Enterobacteriaceae
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)
  • K854732 — API 50 CHB (CULTURE MEDIA) (March 4, 1986)

Other clearances for product code JSS

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  • K123418 — GRAM-NEGATIVE QUICKFISH BC (July 21, 2013)
  • K101558 — GNR TRAFFIC LIGHT PNA FISH (December 16, 2010)
  • K092236 — E.COLI/P. AERUGINOSA PNA FISH (December 16, 2009)
  • K092393 — EK/P. AERUGINOSA PNA FISH (September 1, 2009)
  • K082068 — E. COLI PNA FISH (June 25, 2009)
  • K081433 — EK/P. AERUGINOSA PNA FISH (March 26, 2009)
  • K081309 — E.COLI/P. AERUGINOSA PNA FISH (December 19, 2008)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 1993)
  • K926018 — CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (March 11, 1993)