Chemwell, Also Known AS Project 2900
FDA 510(k) K013420 · Awareness Technology, Inc.
510(k) numberK013420
Submission
- Device name
- Chemwell, Also Known AS Project 2900
- Applicant
- Awareness Technology, Inc.
Palm City, FL, US - Received
- October 15, 2001
- Decision date
- July 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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.
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| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS · Traditional | 02/27/2018SE |
| K010877 | Chemwell, Model 2900CIX · Abbreviated | 05/23/2001SE |
| K974762 | Stat TracksJJQ · Traditional | 01/28/1998SE |
| K943729 | Dye Check Strips 545-630JJY · Traditional | 12/29/1994SE |
| K941394 | Stat Fax 2600JQW · Traditional | 06/03/1994SE |
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | 10/14/1992SE |
| K900224 | Stat FAX(TM)-2100JJQ · Traditional | 03/01/1990SE |
| K892656 | Dri-Dye Check Strips (TM)-405JJX · Traditional | 05/22/1989SE |
| K882938 | Stat Fax(Tm)JJQ · Traditional | 09/09/1988SE |
| K873451 | Project 300 Microassay BP-12, Eia MinilabJJQ · Traditional | 11/04/1987SE |
Questions and answers
When was Chemwell, Also Known AS Project 2900 cleared by the FDA?
Chemwell, Also Known AS Project 2900 (K013420) received a 510(k) decision of Substantially Equivalent on July 19, 2002, 277 days after the submission was received.
What is the product code of K013420?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.