The following data is part of a premarket notification filed by Cal-tech Diagnostics, Inc. with the FDA for Mono Acu-slide Test.
| Device ID | K861211 |
| 510k Number | K861211 |
| Device Name: | MONO ACU-SLIDE TEST |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | CAL-TECH DIAGNOSTICS, INC. 1110 MONTEREY PASS RD. Monterey Park, CA 91754 |
| Contact | Chen, Ph.d. |
| Correspondent | Chen, Ph.d. CAL-TECH DIAGNOSTICS, INC. 1110 MONTEREY PASS RD. Monterey Park, CA 91754 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-11-05 |