ELSA-HCT— 510(k) K951708
Substantially EquivalentCis-Us, Inc.
FDA 510(k) clearance K951708 for ELSA-HCT, Substantially Equivalent on 1995-09-05. Applicant: Cis-Us, Inc.. Device class: 2.
Clearance details
- Applicant
- Cis-Us, Inc.
- Product code
- Code JKR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1140
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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More clearances from Cis-Us, Inc.
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