Atlas FDA

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

FDA 510(k) clearance K090968 · decided 2009-06-04

Clearance details

K-number
K090968
Device name
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
Applicant
Trek Diagnostic Systems, Inc.
Decision
Substantially Equivalent
Date received
2009-04-06
Decision date
2009-06-04
Days to decision
59 days
Clearance type
Traditional
Product code
NGZ
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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VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (K151923)bioMerieux, Inc.2016-03-25
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (K151817)bioMerieux, Inc.2016-02-18
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE (K133952)bioMerieux, Inc.2014-08-19
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Recalls involving this device

RecordFirmDate
Yeastone Broth, 11ML, 10/BOX YY3462 recall (Z-1806-2026)Remel, Inc2026-04-10

PMA approvals by this applicant

RecordFirmDate
SENSITITRE (N50531/S007)Trek Diagnostic Systems, Inc.1984-03-07
SENSITITRE (N50531/S006)Trek Diagnostic Systems, Inc.1983-02-17
SENSITITRE (N50531/S005)Trek Diagnostic Systems, Inc.1982-04-08
SENSITITRE (N50531/S004)Trek Diagnostic Systems, Inc.1981-04-14
SENSITITRE (N50531/S003)Trek Diagnostic Systems, Inc.1980-08-13
SENSITITRE (N50531)Trek Diagnostic Systems, Inc.1979-05-04