IGE/THE OPHYLLINE CONTROL SERUM I,II,III— 510(k) K822133
Substantially EquivalentKallestad Laboratories, Inc.
FDA 510(k) clearance K822133 for IGE/THE OPHYLLINE CONTROL SERUM I,II,III, Substantially Equivalent on 1982-08-03. Applicant: Kallestad Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Kallestad Laboratories, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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