The following data is part of a premarket notification filed by Pacific Biotech, Inc. with the FDA for Cards O.s. Mono.
| Device ID | K902510 |
| 510k Number | K902510 |
| Device Name: | CARDS O.S. MONO |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego, CA 92121 |
| Contact | Shu-ching Cheng |
| Correspondent | Shu-ching Cheng PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego, CA 92121 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-05 |
| Decision Date | 1990-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613201212 | K902510 | 000 |