IRISTAIN FORMULA 2, PARTS 1 AND 2— 510(k) K893530
Substantially EquivalentIntl. Remote Imaging Systems
FDA 510(k) clearance K893530 for IRISTAIN FORMULA 2, PARTS 1 AND 2, Substantially Equivalent on 1989-06-13. Applicant: Intl. Remote Imaging Systems. Device class: 1.
Clearance details
- Applicant
- Intl. Remote Imaging Systems
- Product code
- Code JTS
- Device class
- Class 1
- Regulation
- 21 CFR 864.1850
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chatsworth, CA, US
Recent devices under product code JTS
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