Atlas FDA

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

FDA 510(k) clearance K073424 · decided 2008-01-22

Clearance details

K-number
K073424
Device name
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
Applicant
Trek Diagnostic Systems, Inc.
Decision
Substantially Equivalent
Date received
2007-12-05
Decision date
2008-01-22
Days to decision
48 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

RecordFirmDate
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST recall (Z-0327-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST recall (Z-0328-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST recall (Z-0329-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST recall (Z-0330-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST recall (Z-0331-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST recall (Z-0332-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST recall (Z-0333-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST recall (Z-0334-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST recall (Z-0335-2023)Remel Inc2022-12-08

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