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SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...

FDA 510(k) clearance K111429 · decided 2011-08-18

Clearance details

K-number
K111429
Device name
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
Applicant
Trek Diagnostic Systems, Ltd.
Decision
Substantially Equivalent
Date received
2011-05-23
Decision date
2011-08-18
Days to decision
87 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Cleveland, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed recall (Z-1947-2025)Remel, Inc2025-06-11