The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Eye Spot Crp Test.
| Device ID | K932180 |
| 510k Number | K932180 |
| Device Name: | EYE SPOT CRP TEST |
| Classification | System, Test, C-reactive Protein |
| Applicant | J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Contact | Charles Gill |
| Correspondent | Charles Gill J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-05 |
| Decision Date | 1993-08-23 |