METHYL GREEN-PYRONIN STAIN PROCEDURE HT70
FDA 510(k) clearance K844808 · decided 1985-02-25
Clearance details
- K-number
- K844808
- Device name
- METHYL GREEN-PYRONIN STAIN PROCEDURE HT70
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-11
- Decision date
- 1985-02-25
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- HZA
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- St. Louis, MO, 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 |
|---|---|---|
| METHYL GREEN SOLUTION (K871544) | Sigma Diagnostics, Inc. | 1987-04-29 |
Recalls involving this device
No recalls on record reference this clearance.