The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bac-t-screen.
Device ID | K851399 |
510k Number | K851399 |
Device Name: | BAC-T-SCREEN |
Classification | Kit, Screening, Urine |
Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
Contact | William H Guinty |
Correspondent | William H Guinty MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
Product Code | JXA |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-09 |
Decision Date | 1985-06-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BAC-T-SCREEN 73418323 1299329 Dead/Cancelled |
Marion Laboratories, Inc. 1983-03-22 |