ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353— 510(k) K983416
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K983416 for ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353, Substantially Equivalent on 1998-10-21. Applicant: Boehringer Mannheim Corp.. Device class: 1.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code JGJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1495
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code JGJ
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