TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL— 510(k) K970100
Substantially EquivalentSimplicity Diagnostics, Inc.
FDA 510(k) clearance K970100 for TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL, Substantially Equivalent on 1997-03-10. Applicant: Simplicity Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Simplicity Diagnostics, Inc.
- Product code
- Code MJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hatboro, PA, US
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