Atlas FDA

MICROSCAN MICROSTREP PLUS PANEL

FDA 510(k) clearance K061872 · decided 2006-08-23

Clearance details

K-number
K061872
Device name
MICROSCAN MICROSTREP PLUS PANEL
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2006-07-03
Decision date
2006-08-23
Days to decision
51 days
Clearance type
Traditional
Product code
LRG
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

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MICROSCAN (R) MICROSTREP PLUS (R) PANELS (K111205)Siemens Healthcare Diagnostics, Inc.2011-07-20
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (K101425)Siemens Healthcare Diagnostics2010-09-10
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN (K081013)Siemens Healthcare Diagnostics2008-09-08
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN (K071316)Dade Behring, Inc.2007-08-20
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN (K063299)Dade Behring, Inc.2006-11-27
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) (K063102)Dade Behring, Inc.2006-11-09
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) (K063099)Dade Behring, Inc.2006-11-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02