RANDOX BILIRUBIN
FDA 510(k) clearance K973995 · decided 1997-12-08
Clearance details
- K-number
- K973995
- Device name
- RANDOX BILIRUBIN
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-21
- Decision date
- 1997-12-08
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- GIG
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Crumlin, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HBM HEMOGLOBINOMETER (K933836) | Artel, Inc. | 1994-03-31 |
| HEMOGLOBIN ANALYZER & PERFORM. CHECK SET (K771101) | The Dow Chemical Co. | 1977-07-21 |
Recalls involving this device
No recalls on record reference this clearance.