Opus TSH Test System
FDA 510(k) K902333 · Pb Diagnostic Systems, Inc.
510(k) numberK902333
Submission
- Device name
- Opus TSH Test System
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- May 24, 1990
- Decision date
- July 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1690
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JLW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/06/2026SE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | Siemens Healthcare Diagnostics | 04/25/2025SE |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0JLW · Traditional | Genalyte, Inc. | 07/22/2024SE |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII)JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/04/2024SE |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…JLW · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2023SE |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerJLW · Traditional | Beckman Coulter, Inc. | 11/10/2022SE |
| K190773 | Elecsys TSHJLW · Traditional | Roche Diagnostics | 04/16/2019SE |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerJLW · Traditional | Boditech Med, Inc. | 10/13/2017SE |
| K171103 | Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional | Fujirebio Diagnostics,Inc. | 07/28/2017SE |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW · Traditional | Shenzhen New Industries Biomedical Engineering… | 07/14/2017SE |
More from Shenzhen New Industries Biomedical Engineering Co., Ltd.
| 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 |
| 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 |
Questions and answers
When was Opus TSH Test System cleared by the FDA?
Opus TSH Test System (K902333) received a 510(k) decision of Substantially Equivalent on July 5, 1990, 42 days after the submission was received.
What is the product code of K902333?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.