Medical Device Manufacturer · US , Washington , DC

Flexsite Diagnostics, Inc.

2 submissions · 2 cleared · Since 1997
2
Total
2
Cleared
0
Denied

Flexsite Diagnostics, Inc. — FDA 510(k) Submissions

Flexsite Diagnostics, Inc. has submitted 2 FDA 510(k) premarket notifications since 1997, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Indicator Method, Protein Or Albumin (urinary, Non-quant.), Assay, Glycosylated Hemoglobin . Use the specialty filter in the sidebar to narrow results.

2 devices
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All2 Chemistry 1 Hematology 1