Modified TSH Irma Kit
FDA 510(k) K883742 · Pacific Biotech, Inc.
510(k) numberK883742
Submission
- Device name
- Modified TSH Irma Kit
- Applicant
- Pacific Biotech, Inc.
San Diego, CA, US - Received
- September 1, 1988
- Decision date
- January 3, 1989
- 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 |
|---|---|---|
| K924461 | Strep a Negative ControlGTZ · Traditional | 12/02/1993SE |
| K902510 | Cards O.S. MonoKTN · Traditional | 07/16/1990SE |
| K896482 | Perfect(Tm) One Step Early Pregnancy Test KitLCX · Traditional | 03/06/1990SE |
| K896221 | Cards O.S.(Tm) Strep aGTZ · Traditional | 12/13/1989SE |
| K895390 | Cards O.S. (TM) Hcg-UrineJHI · Traditional | 11/13/1989SE |
| K891770 | HCG Irma IIJHI · Traditional | 05/24/1989SE |
| K884616 | Firstday Early Pregnancy Testing Kit IIJHI · Traditional | 01/13/1989SE |
| K884007 | Cards(Tm) MonoKTN · Traditional | 11/18/1988SE |
| K882895 | Modified Beta Quik Stat Eia KitDHA · Traditional | 10/12/1988SE |
| K883639 | Modified HCG Irma KitJHI · Traditional | 10/06/1988SE |
Questions and answers
When was Modified TSH Irma Kit cleared by the FDA?
Modified TSH Irma Kit (K883742) received a 510(k) decision of Substantially Equivalent on January 3, 1989, 124 days after the submission was received.
What is the product code of K883742?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.