510(k) K821503
K821503 is an FDA 510(k) premarket notification submitted by Intl. Remote Imaging Systems for the device "IRIS URINE STAIN". The FDA issued a decision of Substantially Equivalent on June 3, 1982. The device falls under product code ICF (Crystal Violet For Histology), a Class I device regulated under 21 CFR 864.1850. Intl. Remote Imaging Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1982
- Date Received
- May 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crystal Violet For Histology
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type