COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.— 510(k) K895648
Substantially EquivalentVentrex Laboratories, Inc.
FDA 510(k) clearance K895648 for COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN., Substantially Equivalent on 1990-01-18. Applicant: Ventrex Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Ventrex Laboratories, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, ME, US
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