Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control
FDA 510(k) K970100 · Simplicity Diagnostics, Inc.
510(k) numberK970100
Submission
- Device name
- Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control
- Applicant
- Simplicity Diagnostics, Inc.
Hatboro, PA, US - Received
- January 10, 1997
- Decision date
- March 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MJX – Kit, Serological, Positive Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MJX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101434 | Audit Microcv Procalcitonin LinearityMJX · Traditional | Aalto Scientific, Ltd. | 07/22/2010SE |
| K030067 | Vitros Immunodiagnostic Products Hbsag ControlsMJX · Traditional | Ortho-Clinical Diagnostics | 01/17/2003SE |
| K974262 | Syscos Idc - G, Idc, BSC, Idc - GMJX · Traditional | Scantibodies Laboratory, Inc. | 12/24/1997SE |
| K972986 | Accurun 140 Rubella Igg Positive ControlMJX · Traditional | Boston Biomedica, Inc. | 10/08/1997SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | Pb Diagnostic Systems, Inc. | 03/07/1994SE |
| K925703 | Opus Serology ControlsMJX · Traditional | Pb Diagnostics, Inc. | 04/08/1993SE |
More from Pb Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922726 | Tech Simple Infectious Mononucleosis Serum ControlKTN · Traditional | 10/05/1992SE |
| K922725 | Tech Simple Rheumatoid Factor Serum ControlDHR · Traditional | 10/05/1992SE |
| K922722 | Tech Dimple C-Reactive Protein Serum ControlDCK · Traditional | 10/05/1992SE |
| K922723 | Tech Simple Antistreptolysin O Aso Serum ControlGTQ · Traditional | 09/18/1992SE |
Questions and answers
When was Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control cleared by the FDA?
Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control (K970100) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 59 days after the submission was received.
What is the product code of K970100?
The FDA product code is MJX – Kit, Serological, Positive Control, a Class I (low risk) device regulated under 21 CFR 862.1660.