OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.— 510(k) K810077
Substantially EquivalentHyland Therapeutic Div., Travenol Laboratories
FDA 510(k) clearance K810077 for OMEGA THERAPEUTIC DRUG MONIT. CONTROL S., Substantially Equivalent on 1981-01-28. Applicant: Hyland Therapeutic Div., Travenol Laboratories. Device class: 1.
Clearance details
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Product code
- Code DIF
- 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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More clearances from Hyland Therapeutic Div., Travenol Laboratories
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