The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for C-reactive Protein Elisa, Model Number Dsl-10-42100.
| Device ID | K981871 |
| 510k Number | K981871 |
| Device Name: | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | John Class |
| Correspondent | John Class DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-28 |
| Decision Date | 1998-11-09 |
| Summary: | summary |