510(k) K851508

NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS by Nikon, Inc. — Product Code LNJ

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