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510(k) K926248

READER by Alamar Biosciences Laboratory, Inc. — Product Code LRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1994
Date Received
December 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument For Auto Reader Of Overnight Microorganism Identification System
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)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 1993)
  • 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 LRH

  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K961042 — MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL (May 30, 1996)
  • K920225 — AUTOSCEPTOR IDENTIFICATION SYSTEM (May 22, 1992)