NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
FDA 510(k) clearance K994140 · decided 2000-05-09
Clearance details
- K-number
- K994140
- Device name
- NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
- Applicant
- Nichols Institute Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1999-12-08
- Decision date
- 2000-05-09
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- MSW
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Juan Capistrano, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Elecsys Tg II (K221890) | Roche Diagnostics | 2023-09-30 |
| Access Thyroglobulin (K220972) | Beckman Coulter, Inc. | 2023-09-15 |
| ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (K031269) | Beckman Coulter, Inc. | 2003-05-02 |
| BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (K021057) | Brahms Diagnostica, LLC | 2002-09-17 |
| NICHOLS ADVANTAGE THYROGLOB (K002888) | Nichols Institute Diagnostics | 2000-10-20 |
| ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (K002905) | Beckman Coulter, Inc. | 2000-10-19 |
| KRONUS OPTIQUANT THYROGLOBULIN KIT (K991720) | Unchanged | 1999-08-09 |
| IMMULITE THYROGLOBULIN MODEL LKTY (K982466) | Diagnostic Products Corp. | 1999-03-12 |
| IMMULITE 2000 THYROGLOBULIN MODEL L2KTY (K982468) | Diagnostic Products Corp. | 1999-03-12 |
Recalls involving this device
No recalls on record reference this clearance.