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510(k) K854733

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

K854733 is an FDA 510(k) premarket notification submitted by Dms Products, Inc. for the device "API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), 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
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

  • K150031 — hemoFISH Masterpanel (October 1, 2015)
  • 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)
  • K926017 — CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (March 11, 1993)

FDA data resources