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510(k) K961042

MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL by Dade Microscan, Inc. — Product Code LRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
March 14, 1996
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 Dade Microscan, Inc.

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  • K021184 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN (June 20, 2002)
  • K021181 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN (June 17, 2002)
  • K021018 — MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL (June 11, 2002)
  • K021110 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE (June 6, 2002)
  • K021169 — MICROSTREP PLUS PANEL, AZITHROMYCIN (June 6, 2002)
  • K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN (June 6, 2002)
  • K021188 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME (June 6, 2002)
  • K021111 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME (June 6, 2002)

Other clearances for product code LRH

  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K926248 — READER (May 17, 1994)
  • K920225 — AUTOSCEPTOR IDENTIFICATION SYSTEM (May 22, 1992)