The following data is part of a premarket notification filed by A-kem, Inc. with the FDA for Creatinine Reagent Kit.
| Device ID | K873131 |
| 510k Number | K873131 |
| Device Name: | CREATININE REAGENT KIT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | A-KEM, INC. P.O. BOX 1589 82 INDUSTRIAL EAST Clifton, NJ 07015 |
| Contact | Steven Lee |
| Correspondent | Steven Lee A-KEM, INC. P.O. BOX 1589 82 INDUSTRIAL EAST Clifton, NJ 07015 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-10 |
| Decision Date | 1987-10-23 |