The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Second Antibody.
| Device ID | K781070 |
| 510k Number | K781070 |
| Device Name: | SECOND ANTIBODY |
| Classification | Second Antibody (species Specific Anti-animal Gamma Globulin) |
| Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTS |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-26 |
| Decision Date | 1978-08-10 |