MUCI-CARMINE STAIN, MAYER'S FORMULA
FDA 510(k) clearance K842925 · decided 1984-09-11
Clearance details
- K-number
- K842925
- Device name
- MUCI-CARMINE STAIN, MAYER'S FORMULA
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-25
- Decision date
- 1984-09-11
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- HZC
- 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 |
|---|---|---|
| MUCICARMINE STAIN, #HT30 (K832953) | Sigma Chemical Co. | 1983-09-29 |
Recalls involving this device
No recalls on record reference this clearance.