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 |