TSH Enzyme Immunoassay Test Kit, Model #BC-1001
FDA 510(k) K991146 · Biocheck, Inc.
510(k) numberK991146
Submission
- Device name
- TSH Enzyme Immunoassay Test Kit, Model #BC-1001
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- April 5, 1999
- Decision date
- June 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
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| K002294 | Biocheck Testosterone Eia, Model BC-1115CDZ · Traditional | 10/02/2000SE |
| K001022 | Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model BC-1061JZG · Traditional | 09/26/2000SE |
| K992517 | Biocheck Ferritin Elisa Model BC-1025DBF · Traditional | 09/24/1999SE |
| K992528 | Biocheck Ige Elisa, Model BC-1035DGC · Traditional | 09/21/1999SE |
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Questions and answers
When was TSH Enzyme Immunoassay Test Kit, Model #BC-1001 cleared by the FDA?
TSH Enzyme Immunoassay Test Kit, Model #BC-1001 (K991146) received a 510(k) decision of Substantially Equivalent on June 22, 1999, 78 days after the submission was received.
What is the product code of K991146?
The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.