The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for In Vitro Diagnostic Reagent Set, Indir. Preg. Test.
Device ID | K921968 |
510k Number | K921968 |
Device Name: | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST |
Classification | Agglutination Method, Human Chorionic Gonadotropin |
Applicant | TECH-CO, INC. 911 VIA RODEO Placentia, CA 92670 |
Contact | K. C Chen |
Correspondent | K. C Chen TECH-CO, INC. 911 VIA RODEO Placentia, CA 92670 |
Product Code | JHJ |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-27 |
Decision Date | 1996-06-28 |