The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Sharia-lh Ria Kit For Quantitation Hormo.
| Device ID | K813213 |
| 510k Number | K813213 |
| Device Name: | SHARIA-LH RIA KIT FOR QUANTITATION HORMO |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | INTL. IMMUNOASSAY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-09 |
| Decision Date | 1981-12-22 |