DIRECT BILIRUBIN— 510(k) K860257
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K860257 for DIRECT BILIRUBIN, Substantially Equivalent on 1986-02-21. Applicant: Pointe Scientific, Inc.,. Device class: 2.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Detroit, MI, US
Recent devices under product code CIG
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