The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Urichemtrak Liquid Assayed Control Levels 1 And 2.
| Device ID | K981933 |
| 510k Number | K981933 |
| Device Name: | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-02 |
| Decision Date | 1998-06-29 |