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Manufacturers
US
Biotrax, Inc.
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Medical Device Manufacturer
·
US , Baltimore , MD
Biotrax, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1990
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biotrax, Inc.
Microbiology
✕
2
devices
1-2 of 2
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Cleared
Jul 24, 1991
CROMATEST SYPHILIS DIAGNOSTIC
K904496
·
GMQ
Microbiology
·
295d
Cleared
Jun 24, 1991
CROATEST (R) RHEUMATOID DIAGNOSTIC
K904416
·
GTQ
Microbiology
·
270d
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4
Immunology
2
Microbiology
2