The following data is part of a premarket notification filed by Gelman Instrument Co. with the FDA for Radial Immunodiffusion Kit-alph-l-antit.
| Device ID | K772080 |
| 510k Number | K772080 |
| Device Name: | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | GELMAN INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-03 |
| Decision Date | 1978-02-03 |