The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Vitamin B12 Folate Radioassay.
| Device ID | K802037 |
| 510k Number | K802037 |
| Device Name: | VITAMIN B12 FOLATE RADIOASSAY |
| Classification | Flowmeter, Nonback-pressure Compensated, Bourdon Gauge |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCN |
| CFR Regulation Number | 868.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-22 |
| Decision Date | 1980-11-21 |