MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA— 510(k) K900706
Substantially EquivalentInnotron of Oregon, Inc.
FDA 510(k) clearance K900706 for MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA, Substantially Equivalent on 1990-04-12. Applicant: Innotron of Oregon, Inc.. Device class: 2.
Clearance details
- Applicant
- Innotron of Oregon, Inc.
- Product code
- Code LGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
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