SUDAN IV HERXHEIMER
FDA 510(k) clearance K842916 · decided 1984-09-11
Clearance details
- K-number
- K842916
- Device name
- SUDAN IV HERXHEIMER
- 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
- KKK
- 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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Recalls involving this device
No recalls on record reference this clearance.