IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE— 510(k) K011586
Substantially EquivalentDiametrics Medical, Inc.
FDA 510(k) clearance K011586 for IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE, Substantially Equivalent on 2001-11-16. Applicant: Diametrics Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Diametrics Medical, Inc.
- Product code
- Code GAA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, MN, US
Recent devices under product code GAA
view allMore clearances from Diametrics Medical, Inc.
view all- K030035 — IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
- K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
- K981270 — IRMA BLOOD ANALYSIS SYSTEM
- K980523 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
- K974396 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
Adverse events under product code GAA
product code GAA- Malfunction
- 834
- Total
- 834
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.