The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Accutex Crp Latex Test.
| Device ID | K924332 |
| 510k Number | K924332 |
| Device Name: | ACCUTEX CRP LATEX TEST |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Contact | Richard Davis |
| Correspondent | Richard Davis J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1992-12-07 |