RANDOX MICROALBUMIN
FDA 510(k) clearance K002674 · decided 2000-10-05
Clearance details
- K-number
- K002674
- Device name
- RANDOX MICROALBUMIN
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-28
- Decision date
- 2000-10-05
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- DDZ
- Device class
- 2
- Regulation number
- 866.5040
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Crumlin, Co. Antrim, IE
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H (K050576) | Good Biotech Corp. | 2005-04-21 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog recall (Z-1594-2024) | Randox Laboratories Ltd. | 2024-04-17 |