TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
FDA 510(k) clearance K970100 · decided 1997-03-10
Clearance details
- K-number
- K970100
- Device name
- TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
- Applicant
- Simplicity Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-10
- Decision date
- 1997-03-10
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- MJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hatboro, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AUDIT MICROCV PROCALCITONIN LINEARITY (K101434) | Aalto Scientific, Ltd. | 2010-07-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K030067) | Ortho-Clinical Diagnostics | 2003-01-17 |
| SYSCOS IDC - G, IDC, BSC, IDC - G (K974262) | Scantibodies Laboratory, Inc. | 1997-12-24 |
| ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (K972986) | Boston Biomedica, Inc. | 1997-10-08 |
| OPUS(R) SEROLOGY CONTROLS, MODIFICATION (K934137) | Pb Diagnostic Systems, Inc. | 1994-03-07 |
| OPUS SEROLOGY CONTROLS (K925703) | Pb Diagnostics, Inc. | 1993-04-08 |
Recalls involving this device
No recalls on record reference this clearance.