The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Test For Human Alpha One Acid Glyco-.
| Device ID | K831960 |
| 510k Number | K831960 |
| Device Name: | TEST FOR HUMAN ALPHA ONE ACID GLYCO- |
| Classification | Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Applicant | KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKL |
| CFR Regulation Number | 866.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-17 |
| Decision Date | 1983-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1761230 | K831960 | 000 |