HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
FDA 510(k) clearance K952077 · decided 1995-06-05
Clearance details
- K-number
- K952077
- Device name
- HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
- Applicant
- Hemagen Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-03
- Decision date
- 1995-06-05
- Days to decision
- 33 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
+ Add to Predicate Builder ◉ Watch Hemagen Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.