VOLU-SOL URINARY DICHROME STAIN
FDA 510(k) clearance K801143 · decided 1980-05-30
Clearance details
- K-number
- K801143
- Device name
- VOLU-SOL URINARY DICHROME STAIN
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1980-05-18
- Decision date
- 1980-05-30
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- IDA
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| BIO SURE STAIN (K832496) | Helena Laboratories | 1983-09-12 |
Recalls involving this device
No recalls on record reference this clearance.