The following data is part of a premarket notification filed by Medastat Scientific Corp. with the FDA for Acid Fast Quality Control Slides.
Device ID | K822604 |
510k Number | K822604 |
Device Name: | ACID FAST QUALITY CONTROL SLIDES |
Classification | Quality Control Slides |
Applicant | MEDASTAT SCIENTIFIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LJG |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-27 |
Decision Date | 1982-09-28 |