TOTAL & DIRECT BILIRUBIN PROCEDURES— 510(k) K832942
Substantially EquivalentSandare Chemical Co., Inc.
FDA 510(k) clearance K832942 for TOTAL & DIRECT BILIRUBIN PROCEDURES, Substantially Equivalent on 1983-11-07. Applicant: Sandare Chemical Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Sandare Chemical Co., 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
- Mchenry, IL, US
Recent devices under product code CIG
view allMore clearances from Sandare Chemical Co., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.