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510(k) K894776

SENSITITRE INDOLE REAGENT by Radiometer America, Inc. — Product Code JSS

K894776 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "SENSITITRE INDOLE REAGENT". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), a Class I device regulated under 21 CFR 866.2660. Radiometer America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1989
Date Received
July 27, 1989
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 Radiometer America, Inc.

  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (January 10, 2000)
  • K991417 — ABL 735 ANALYZER (November 24, 1999)
  • K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (January 6, 1999)
  • K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (February 9, 1998)
  • K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (January 28, 1998)
  • K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (January 16, 1998)
  • K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (October 6, 1997)
  • K962158 — PICO MODELS 30, 50, 70 (October 29, 1996)
  • K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER (October 24, 1996)

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)
  • K926018 — CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (March 11, 1993)

FDA data resources