IRMA BLOOD ANALYSIS SYSTEM
FDA 510(k) clearance K981270 · decided 1998-05-01
Clearance details
- K-number
- K981270
- Device name
- IRMA BLOOD ANALYSIS SYSTEM
- Applicant
- Diametrics Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-07
- Decision date
- 1998-05-01
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- CGZ
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Roseville, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.