510(k) K852665
K852665 is an FDA 510(k) premarket notification submitted by Syncor Intl. Corp. for the device "SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY". The FDA issued a decision of Substantially Equivalent on August 13, 1985. The device falls under product code JWZ (Kit, Screening, Trichomonas), a Class I device regulated under 21 CFR 866.2660. Syncor Intl. Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1985
- Date Received
- June 24, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Screening, Trichomonas
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type