HEP-2 CELLS— 510(k) K831681
Substantially EquivalentViromed Laboratories, Inc.
FDA 510(k) clearance K831681 for HEP-2 CELLS, Substantially Equivalent on 1983-07-06. Applicant: Viromed Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Viromed Laboratories, Inc.
- Product code
- Code KIR
- Device class
- Class 1
- Regulation
- 21 CFR 864.2280
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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