The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Non-fermenter System.
Device ID | K772112 |
510k Number | K772112 |
Device Name: | NON-FERMENTER SYSTEM |
Classification | Kit, Identification, Glucose Nonfermenter |
Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1977-11-07 |
Decision Date | 1977-11-17 |