The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Kova Liqua-trol.
| Device ID | K942853 |
| 510k Number | K942853 |
| Device Name: | KOVA LIQUA-TROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Thomas J Foley |
| Correspondent | Thomas J Foley HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-16 |
| Decision Date | 1994-10-04 |