ORANGE G, 1%
FDA 510(k) clearance K842924 · decided 1984-09-07
Clearance details
- K-number
- K842924
- Device name
- ORANGE G, 1%
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-25
- Decision date
- 1984-09-07
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- HZH
- 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 ORANGE G-6(GILLS-MOD (K822038) | Volu Sol Medical Industries | 1982-08-03 |
| ORANGE G-6 (K811825) | Surgipath | 1981-07-10 |
| VOLU-SOL ORANGE G-6 STAIN (K800323) | Volu Sol Medical Industries | 1980-02-22 |
Recalls involving this device
No recalls on record reference this clearance.