The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Accutex Rheumatiod Factor (rf) Latex Test.
| Device ID | K924036 |
| 510k Number | K924036 |
| Device Name: | ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1992-12-01 |