ELSA-HCT
FDA 510(k) clearance K951708 · decided 1995-09-05
Clearance details
- K-number
- K951708
- Device name
- ELSA-HCT
- Applicant
- Cis-Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-13
- Decision date
- 1995-09-05
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- JKR
- Device class
- 2
- Regulation number
- 862.1140
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.