The following data is part of a premarket notification filed by A-kem, Inc. with the FDA for Calibrator Standard Kit For Astra System.
| Device ID | K884227 |
| 510k Number | K884227 |
| Device Name: | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1988-12-09 |