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510(k) K925951

READAR by Alamar Biosciences Laboratory, Inc. — Product Code LRG

K925951 is an FDA 510(k) premarket notification submitted by Alamar Biosciences Laboratory, Inc. for the device "READAR". The FDA issued a decision of Substantially Equivalent on August 31, 1993. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Alamar Biosciences Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1993
Date Received
November 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Alamar Biosciences Laboratory, Inc.

  • K941425 — ALAMAR ANTIBIOTIC SUSCEPTIBILITY (December 15, 1994)
  • K926248 — READER (May 17, 1994)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 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 LRG

  • K191914 — Thermo Scientific Sensititre ARIS HiQ System (November 6, 2019)
  • K191918 — Thermo Scientific Sensititre ARIS HiQ System (November 6, 2019)
  • K110583 — SENSITITRE OPTIREAD (September 22, 2011)
  • K103532 — AUTOREADER 2 (August 26, 2011)
  • K111677 — MICROSCAN(R) MICROSTREP PLUS(R) (August 4, 2011)
  • K111205 — MICROSCAN (R) MICROSTREP PLUS (R) PANELS (July 20, 2011)
  • K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (September 10, 2010)
  • K081013 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN (September 8, 2008)
  • K071316 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPT (August 20, 2007)
  • K063299 — MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN (November 27, 2006)

FDA data resources