VOLU-SOL SINGLE DIFFERENTIAL STAIN
FDA 510(k) clearance K822128 · decided 1982-08-05
Clearance details
- K-number
- K822128
- Device name
- VOLU-SOL SINGLE DIFFERENTIAL STAIN
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1982-07-19
- Decision date
- 1982-08-05
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- ICN
- 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 |
|---|---|---|
| MASSON TRICHROME STAIN HT15 (K833273) | Sigma Chemical Co. | 1983-10-31 |
Recalls involving this device
No recalls on record reference this clearance.