The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Chem Trak Tri-point Liquid Bilirubin Calibrator,i/.
| Device ID | K851670 |
| 510k Number | K851670 |
| Device Name: | CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ |
| Classification | Calibrator, Secondary |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna Anderson |
| Correspondent | Donna Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-05-10 |