The following data is part of a premarket notification filed by Micro-palettes, Inc. with the FDA for Pseudo-palette Tm.
Device ID | K790992 |
510k Number | K790992 |
Device Name: | PSEUDO-PALETTE TM |
Classification | Kit, Identification, Glucose Nonfermenter |
Applicant | MICRO-PALETTES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSW |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-29 |
Decision Date | 1979-06-22 |