510(k) K822293
K822293 is an FDA 510(k) premarket notification submitted by Kemble Instruments, Inc. for the device "IMMU-COUNT 404". The FDA issued a decision of Substantially Equivalent on August 24, 1982. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Kemble Instruments, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1982
- Date Received
- August 2, 1982
- 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