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510(k) K926002

ALAMAR BACTERIAL IDENTIFICATION TEST PANEL by Alamar Biosciences Laboratory, Inc. — Product Code JSS

K926002 is an FDA 510(k) premarket notification submitted by Alamar Biosciences Laboratory, Inc. for the device "ALAMAR BACTERIAL IDENTIFICATION TEST PANEL". The FDA issued a decision of Substantially Equivalent on September 23, 1993. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), a Class I device regulated under 21 CFR 866.2660. Alamar Biosciences Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1993
Date Received
November 27, 1992
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 Alamar Biosciences Laboratory, Inc.

  • K941425 — ALAMAR ANTIBIOTIC SUSCEPTIBILITY (December 15, 1994)
  • K926248 — READER (May 17, 1994)
  • K925951 — READAR (August 31, 1993)
  • K930469 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (June 25, 1993)
  • K930055 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (April 5, 1993)
  • K924500 — ANTIMICROBIAL SUSCEPTIBILITY TEST (November 30, 1992)
  • K922780 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (August 20, 1992)
  • K922003 — ANTIMICROBIAL SUSCETIBILITY TEST PANEL (August 19, 1992)
  • K922168 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (July 28, 1992)
  • K911558 — ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN (May 15, 1991)

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)
  • K926018 — CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (March 11, 1993)
  • K926017 — CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (March 11, 1993)

FDA data resources