RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
FDA 510(k) clearance K972608 · decided 1997-08-04
Clearance details
- K-number
- K972608
- Device name
- RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-11
- Decision date
- 1997-08-04
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Crumlin, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum recall (Z-0903-2023) | Randox Laboratories Ltd. | 2023-01-05 |
| Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality c recall (Z-0904-2023) | Randox Laboratories Ltd. | 2023-01-05 |
| Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality c recall (Z-0905-2023) | Randox Laboratories Ltd. | 2023-01-05 |
| Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682 recall (Z-2278-2018) | Randox Laboratories Ltd. | 2018-06-13 |
| Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683 recall (Z-2279-2018) | Randox Laboratories Ltd. | 2018-06-13 |
| Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684 recall (Z-2280-2018) | Randox Laboratories Ltd. | 2018-06-13 |