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510(k) K912924

RAMBACH AGAR by Rantran, Inc. — Product Code JSS

K912924 is an FDA 510(k) premarket notification submitted by Rantran, Inc. for the device "RAMBACH AGAR". The FDA issued a decision of Substantially Equivalent on February 28, 1992. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), a Class I device regulated under 21 CFR 866.2660. Rantran, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1992
Date Received
July 3, 1991
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 Rantran, Inc.

  • K932138 — SALINE FOR IRRIGATION (November 4, 1994)
  • K926526 — LATEX EXAMINATION GLOVES (POWDER FREE) (August 24, 1993)
  • K923698 — BETAMIST 2 (February 18, 1993)

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