The following data is part of a premarket notification filed by Giles Scientific, Inc. with the FDA for Biomic Video Plate Reader.
Device ID | K932122 |
510k Number | K932122 |
Device Name: | BIOMIC VIDEO PLATE READER |
Classification | Reader, Zone, Automated |
Applicant | GILES SCIENTIFIC, INC. 250 MERCER ST. SUITE A301 New York, NY 10012 |
Contact | David L Gibbs |
Correspondent | David L Gibbs GILES SCIENTIFIC, INC. 250 MERCER ST. SUITE A301 New York, NY 10012 |
Product Code | KZK |
CFR Regulation Number | 866.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-03 |
Decision Date | 1994-03-01 |