IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE— 510(k) K030035
Substantially EquivalentDiametrics Medical, Inc.
FDA 510(k) clearance K030035 for IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE, Substantially Equivalent on 2003-06-25. Applicant: Diametrics Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Diametrics Medical, Inc.
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, MN, US
Recent devices under product code JFY
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- K974396 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
Data sourced from openFDA. This site is unofficial and independent of the FDA.