The following data is part of a premarket notification filed by Nikon Inc. with the FDA for Nikon/joyce Lock Magican 2 Chromosome Sys.
Device ID | K851508 |
510k Number | K851508 |
Device Name: | NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS |
Classification | Analyzer, Chromosome, Automated |
Applicant | NIKON INC. 623 STEWART AVE. GARDEN CITY, NY 11530 |
Contact | ROBERT CHU |
Correspondent | ROBERT CHU NIKON INC. 623 STEWART AVE. GARDEN CITY, NY 11530 |
Product Code | LNJ |
CFR Regulation Number | 864.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-15 |
Decision Date | 1985-07-12 |