510(k) K921428
K921428 is an FDA 510(k) premarket notification submitted by Capintec Instruments, Inc. for the device "CAPTUS 500". The FDA issued a decision of Substantially Equivalent on May 28, 1992. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Capintec Instruments, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1992
- Date Received
- March 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Uptake, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1320
- Review Panel
- RA
- Submission Type