510(k) K802120
K802120 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "HEPA-SHURE -L". The FDA issued a decision of Substantially Equivalent on October 20, 1980. The device falls under product code JJK (Oncometer, Plasma, For Clinical Use), a Class I device regulated under 21 CFR 862.2720. Nuclear Medical Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1980
- Date Received
- September 4, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oncometer, Plasma, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2720
- Review Panel
- CH
- Submission Type