The following data is part of a premarket notification filed by A-kem, Inc. with the FDA for Total Bilirubin Reagent Kit For Astra Systems.
| Device ID | K884224 |
| 510k Number | K884224 |
| Device Name: | TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1988-12-15 |