The following data is part of a premarket notification filed by Q.i. Medical, Inc. with the FDA for Quicktest System.
| Device ID | K920015 |
| 510k Number | K920015 |
| Device Name: | QUICKTEST SYSTEM |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Q.I. MEDICAL, INC. C/O HEDMAN & ASSOCIATES 349 BROCK ROAD Nevada City, CA 95959 |
| Contact | Hilary R Hedman |
| Correspondent | Hilary R Hedman Q.I. MEDICAL, INC. C/O HEDMAN & ASSOCIATES 349 BROCK ROAD Nevada City, CA 95959 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-02 |
| Decision Date | 1992-11-23 |