HEMAGEN ENA SCL-70 KIT (EIA METHOD)
FDA 510(k) clearance K915282 · decided 1992-02-12
Clearance details
- K-number
- K915282
- Device name
- HEMAGEN ENA SCL-70 KIT (EIA METHOD)
- Applicant
- Hemagen Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-25
- Decision date
- 1992-02-12
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.