TITAN GE/IEPLATE— 510(k) K831603
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K831603 for TITAN GE/IEPLATE, Substantially Equivalent on 1983-07-07. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JZR
- Device class
- Class 1
- Regulation
- 21 CFR 866.4900
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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