The following data is part of a premarket notification filed by J. D. Assoc. with the FDA for Creatinine-e.
| Device ID | K863078 |
| 510k Number | K863078 |
| Device Name: | CREATININE-E |
| Classification | Enzymatic Method, Creatinine |
| Applicant | J. D. ASSOC. 163 MONTCLAIR AVE. Montclair, NJ 07042 |
| Contact | Di Pietro |
| Correspondent | Di Pietro J. D. ASSOC. 163 MONTCLAIR AVE. Montclair, NJ 07042 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-12 |
| Decision Date | 1986-09-09 |