The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Micro-mat System.
Device ID | K854962 |
510k Number | K854962 |
Device Name: | MICRO-MAT SYSTEM |
Classification | Spinner, Slide, Automated |
Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Contact | Robert K Mcewen |
Correspondent | Robert K Mcewen ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Product Code | GKJ |
CFR Regulation Number | 864.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-11 |
Decision Date | 1985-12-23 |