510(k) K851508
K851508 is an FDA 510(k) premarket notification submitted by Nikon, Inc. for the device "NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS". The FDA issued a decision of Substantially Equivalent on July 12, 1985. The device falls under product code LNJ (Analyzer, Chromosome, Automated), a Class II device regulated under 21 CFR 864.5260. Nikon, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1985
- Date Received
- April 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chromosome, Automated
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- PA
- Submission Type