The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Hatch Kit.
| Device ID | K831855 |
| 510k Number | K831855 |
| Device Name: | HATCH KIT |
| Classification | Radioimmunoassay, Acth |
| Applicant | RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-09 |
| Decision Date | 1983-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830022283 | K831855 | 000 |
| 00817830022276 | K831855 | 000 |