510(k) K852434
K852434 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "1208 BETACORD AND 1208 BETCORD M". The FDA issued a decision of Substantially Equivalent on August 2, 1985. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1985
- Date Received
- June 10, 1985
- 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