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Manufacturers
US
Solarcare, Inc.
Medical Device Manufacturer
·
US , Bethlehem , PA
Solarcare, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1993
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Solarcare, Inc.
Toxicology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 14, 1995
STC COCAINE METABOLITE EIA
K934775
·
DIO
Toxicology
·
647d
Cleared
Feb 08, 1995
STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA
K944372
·
JXN
Toxicology
·
154d
Cleared
Dec 07, 1993
STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
K934376
·
DIS
Toxicology
·
89d
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6
Toxicology
3
Chemistry
2
General & Plastic Surgery
1