The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Vitamin B12 Folate Defic. Contr..
| Device ID | K810952 |
| 510k Number | K810952 |
| Device Name: | CORNING VITAMIN B12 FOLATE DEFIC. CONTR. |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-07 |
| Decision Date | 1981-04-17 |