The following data is part of a premarket notification filed by Amtec Diagnostics International, Inc. with the FDA for Acute Phase C-reactive Protein Latex Agglu. Test.
| Device ID | K882998 |
| 510k Number | K882998 |
| Device Name: | ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | AMTEC DIAGNOSTICS INTERNATIONAL, INC. 1107 IH-45 SOUTH P.O. BOX 2968 Conroe, TX 77305 |
| Contact | Helen Johnson |
| Correspondent | Helen Johnson AMTEC DIAGNOSTICS INTERNATIONAL, INC. 1107 IH-45 SOUTH P.O. BOX 2968 Conroe, TX 77305 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-18 |
| Decision Date | 1988-09-07 |