The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Gestate Slide Eiken Kit Agg. Method Hum.
Device ID | K802450 |
510k Number | K802450 |
Device Name: | GESTATE SLIDE EIKEN KIT AGG. METHOD HUM |
Classification | Agglutination Method, Human Chorionic Gonadotropin |
Applicant | SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JHJ |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-08 |
Decision Date | 1980-10-31 |