The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Accutex Sle Latex Test.
| Device ID | K924248 |
| 510k Number | K924248 |
| Device Name: | ACCUTEX SLE LATEX TEST |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-24 |
| Decision Date | 1992-11-02 |