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 |