The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for 1f Blocking Antibody(57 Co) Radioassay.
| Device ID | K811927 |
| 510k Number | K811927 |
| Device Name: | 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY |
| Classification | Radioassay, Intrinsic Factor Blocking Antibody |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIG |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-06 |
| Decision Date | 1982-04-01 |