The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Early Pregnancy Detection Kit.
Device ID | K781487 |
510k Number | K781487 |
Device Name: | EARLY PREGNANCY DETECTION KIT |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-28 |
Decision Date | 1978-10-11 |