BIO SURE STAIN
FDA 510(k) clearance K832496 · decided 1983-09-12
Clearance details
- K-number
- K832496
- Device name
- BIO SURE STAIN
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-07-27
- Decision date
- 1983-09-12
- Days to decision
- 47 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 |
|---|---|---|
| VOLU-SOL URINARY DICHROME STAIN (K801143) | Volu Sol Medical Industries | 1980-05-30 |
Recalls involving this device
No recalls on record reference this clearance.