THEOPHYLLINE CONTROL SERUM— 510(k) K780961
Substantially EquivalentVitek Systems, Inc.
FDA 510(k) clearance K780961 for THEOPHYLLINE CONTROL SERUM, Substantially Equivalent on 1978-12-07. Applicant: Vitek Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Vitek Systems, Inc.
- Product code
- Code LAS
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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