BILIRUBIN STANDARD-LYOPHILIZED— 510(k) K830469
Substantially EquivalentDow Instruments & Reagents, Inc.
FDA 510(k) clearance K830469 for BILIRUBIN STANDARD-LYOPHILIZED, Substantially Equivalent on 1983-03-24. Applicant: Dow Instruments & Reagents, Inc.. Device class: 2.
Clearance details
- Applicant
- Dow Instruments & Reagents, 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
- Mchenry, IL, US
Recent devices under product code JIT
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