510(k) K961491
- Device
- ELECSYS TSH ASSAY
- Applicant
- BOEHRINGER MANNHEIM CORP.
- 510(k) number
- K961491
- Product code
- JLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-22
- Date received
- 1996-04-18
- Regulation
- 862.1690
- Classification name
- Radioimmunoassay, Thyroid-stimulating Hormone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETSY SOARES-MADDOX
- Address
- 2400 Bisso Ln. P.O. Box 4117 Concord CA US 94524 94524
FDA Registration Numbers#
- 3015969360
- 3005094123
- 3006198300
- 3050015
- 3002800697
- 1063851
- 3006677029
- 3005360469
- 3003795116
- 3007349751
- 3003030793
- 3043127647
- 9680746
- 9614673
- 8043909
- 2245285
- 2050012
- 3005333358
- 9615037
- 3010324880
- 3022178699
- 2432235
- 1319809
- 9613959
- 3004434309
- 3012963943
- 1832216
- 2250051
- 1317202
- 1319808
- 3010421384
- 3002809144
- 9612316
- 3009711478
- 3009491259
- 2020726
- 3009518015
- 1036362
- 2517506
- 2032087
- 3009092698
- 3020917535
- 2122870
- 8031673
- 1827821
- 3011989923
- 2032682
- 3002637618
- 3033967997
- 3002642396
- 3012073813
- 3005984081
- 3008583799
- 3010825766
- 3003917514
- 8020888
- 1219913
- 9610240
- 3005529799
- 3007111389
- 9610126
- 2029372
- 2030633
- 1319681
- 3014279513
- 3000308930
- 3002806944
- 3027519599
- 3005655287
- 8020790
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code JLW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics | 2025-04-25 |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | 2024-07-22 |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2024-04-04 |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | 2022-11-10 |
| K190773 | Elecsys TSH | Roche Diagnostics | 2019-04-16 |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | Boditech Med, Inc. | 2017-10-13 |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | 2017-07-28 |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017-07-14 |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | 2017-01-23 |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | Sysmex America, Inc. | 2016-10-21 |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2016-08-18 |
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2016-05-31 |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | Siemens Healthcare Diagnostics, Inc. | 2015-11-20 |
Legacy Summary#
summary
FDA Review#
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