The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Ms-2 Identification System.
Device ID | K802309 |
510k Number | K802309 |
Device Name: | MS-2 IDENTIFICATION SYSTEM |
Classification | Kit, Identification, Yeast |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | JXB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-23 |
Decision Date | 1980-12-01 |