Atlas FDA

SUSCEPTIBILITY TEST PANEL

FDA 510(k) clearance K004045 · decided 2001-03-06

Clearance details

K-number
K004045
Device name
SUSCEPTIBILITY TEST PANEL
Applicant
Trek Diagnostic Systems, Inc.
Decision
Substantially Equivalent
Date received
2000-12-29
Decision date
2001-03-06
Days to decision
67 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Westlake, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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