The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Leap Strep Test Kit.
| Device ID | K833738 |
| 510k Number | K833738 |
| Device Name: | LEAP STREP TEST KIT |
| Classification | Exoenzymes, Multiple, Streptococcal |
| Applicant | COOPER BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTP |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-25 |
| Decision Date | 1983-12-27 |