Opus FT4 Test System
FDA 510(k) K940507 · Pb Diagnostic Systems, Inc.
510(k) numberK940507
Submission
- Device name
- Opus FT4 Test System
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- February 2, 1994
- Decision date
- July 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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| K132058 | Vidas FT4CEC · Traditional | Biomerieux S.A. | 06/08/2015SE |
| K140859 | Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional | Roche Diagnostics | 01/27/2014SE |
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|---|---|---|
| K934762 | Opus Procainamide Test SystemLAR · Traditional | 07/20/1994SE |
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| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | 03/07/1994SE |
| 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 FT4 Test System cleared by the FDA?
Opus FT4 Test System (K940507) received a 510(k) decision of Substantially Equivalent on July 28, 1994, 176 days after the submission was received.
What is the product code of K940507?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.