510(k) K832002
K832002 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "NML-5010/5020 MULTI-DETECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 8, 1983. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 8, 1983
- Date Received
- Jun 22, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Counter (Beta, Gamma) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2320
- Review Panel
- CH
- Submission Type
- 510(k) Exempt