The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for Eye Spot Im Test.
Device ID | K932688 |
510k Number | K932688 |
Device Name: | EYE SPOT IM TEST |
Classification | System, Test, Infectious Mononucleosis |
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 | KTN |
CFR Regulation Number | 866.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-03 |
Decision Date | 1993-09-08 |