The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Accutex Im Latex Test.
| Device ID | K932551 |
| 510k Number | K932551 |
| Device Name: | ACCUTEX IM LATEX TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Contact | Charles Gills |
| Correspondent | Charles Gills J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-26 |
| Decision Date | 1993-08-09 |