The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Micro-sample Osmometer 3m0.
Device ID | K832783 |
510k Number | K832783 |
Device Name: | MICRO-SAMPLE OSMOMETER 3M0 |
Classification | Osmometer For Clinical Use |
Applicant | ADVANCED INSTRUMENTS, INC. SHORASHIM |
Product Code | JJM |
CFR Regulation Number | 862.2730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-16 |
Decision Date | 1983-11-28 |