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FAS FASTIDIOUS MIC PANEL

FDA 510(k) clearance K935485 · decided 1995-02-16

Clearance details

K-number
K935485
Device name
FAS FASTIDIOUS MIC PANEL
Applicant
Microtech Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1993-11-15
Decision date
1995-02-16
Days to decision
458 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Aurora, CO, 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
MIC TEST PANELS (N50487/S015)Microtech Medical Systems, Inc.1984-03-01
MIC TEST PANELS (N50487/S011)Microtech Medical Systems, Inc.1982-11-16
MIC TEST PANELS (N50487/S012)Microtech Medical Systems, Inc.1982-11-16
MIC TEST PANELS (N50487/S013)Microtech Medical Systems, Inc.1982-10-08
MIC TEST PANELS (N50487/S010)Microtech Medical Systems, Inc.1981-09-22
MIC TEST PANELS (N50487/S006)Microtech Medical Systems, Inc.1981-05-06
MIC TEST PANELS (N50487/S008)Microtech Medical Systems, Inc.1981-05-06
UTI MIC TEST PANEL (N50487/S007)Microtech Medical Systems, Inc.1981-05-06