UROPAPER EIKEG— 510(k) K811815
Substantially EquivalentSyn-Kit, Inc.
FDA 510(k) clearance K811815 for UROPAPER EIKEG, Substantially Equivalent on 1981-12-10. Applicant: Syn-Kit, Inc.. Device class: 2.
Clearance details
- Applicant
- Syn-Kit, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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