The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Certain Tm.
Device ID | K820873 |
510k Number | K820873 |
Device Name: | CORNING CERTAIN TM |
Classification | Controls For Blood-gases, (assayed And Unassayed) |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJS |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-29 |
Decision Date | 1982-04-16 |