25-HYDROXYVITAMIN D 125I RIA KIT
FDA 510(k) clearance K983617 · decided 1998-11-16
Clearance details
- K-number
- K983617
- Device name
- 25-HYDROXYVITAMIN D 125I RIA KIT
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-15
- Decision date
- 1998-11-16
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- LCI
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA (K801037) | Union Carbide Corp. | 1980-05-28 |
| SYSTEM 6000 AUTOMATED RIA ANALYZER (K780886) | Beckman Instruments, Inc. | 1978-09-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D recall (Z-0705-05) | Diasorin Inc. | 2005-04-13 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021) | DiaSorin, Inc. | 2025-10-10 |