The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Doa - Immunoassay Cut-off Calibrator.
| Device ID | K945289 |
| 510k Number | K945289 |
| Device Name: | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR |
| Classification | Calibrators, Drug Mixture |
| Applicant | MEDI-TECH, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael D Bick |
| Correspondent | Michael D Bick MEDI-TECH, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-31 |
| Decision Date | 1994-12-13 |