510(k) K841352
K841352 is an FDA 510(k) premarket notification submitted by Nuclear Data, Inc. for the device "ND1200 RIA COUNTER". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Nuclear Data, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1984
- Date Received
- April 2, 1984
- 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