510(k) K761290
K761290 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "COMPU-PET 300". The FDA issued a decision of Substantially Equivalent on Feb 24, 1977. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 24, 1977
- Date Received
- Dec 21, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Station, Pipetting And Diluting, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2750
- Review Panel
- CH
- Submission Type
- 510(k) Exempt