Opus(R) Serology Controls, Modification
FDA 510(k) K934137 · Pb Diagnostic Systems, Inc.
510(k) numberK934137
Submission
- Device name
- Opus(R) Serology Controls, Modification
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- August 25, 1993
- Decision date
- March 7, 1994
- 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 |
| K970100 | Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum ControlMJX · Traditional | Simplicity Diagnostics, Inc. | 03/10/1997SE |
| K925703 | Opus Serology ControlsMJX · Traditional | Pb Diagnostics, Inc. | 04/08/1993SE |
More from Pb Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940507 | Opus FT4 Test SystemCEC · Traditional | 07/28/1994SE |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | 07/20/1994SE |
| K933389 | Opus Cmv-GLFZ · Traditional | 06/28/1994SE |
| K935229 | Opus DigitoxinDPG · Traditional | 12/22/1993SE |
| K934705 | Opus NapaLAN · Traditional | 11/22/1993SE |
| K933675 | Opus Total CKCGS · Traditional | 09/08/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | 09/08/1993SE |
| K932279 | Opus(R) Total B-Hcg Test SystemJHI · Traditional | 07/08/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | 06/07/1993SE |
| K924957 | Opus(R) VancomycinLEH · Traditional | 12/11/1992SE |
Questions and answers
When was Opus(R) Serology Controls, Modification cleared by the FDA?
Opus(R) Serology Controls, Modification (K934137) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 194 days after the submission was received.
What is the product code of K934137?
The FDA product code is MJX – Kit, Serological, Positive Control, a Class I (low risk) device regulated under 21 CFR 862.1660.