The following data is part of a premarket notification filed by Cambridge Diagnostic Products, Inc. with the FDA for Mini S.f.t. (urine Preservative).
| Device ID | K943466 |
| 510k Number | K943466 |
| Device Name: | MINI S.F.T. (URINE PRESERVATIVE) |
| Classification | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Applicant | CAMBRIDGE DIAGNOSTIC PRODUCTS, INC. 6880 N.W. 17TH AVE. Ft. Lauderdale, FL 33309 |
| Contact | Jack H Gold |
| Correspondent | Jack H Gold CAMBRIDGE DIAGNOSTIC PRODUCTS, INC. 6880 N.W. 17TH AVE. Ft. Lauderdale, FL 33309 |
| Product Code | LXG |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-15 |
| Decision Date | 1995-05-24 |