The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Aution Max Model Ax-4030 Urinalysis System.
| Device ID | K093098 |
| 510k Number | K093098 |
| Device Name: | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM |
| Classification | Automated Urinalysis System |
| Applicant | ARKRAY, INC. 1201 RICHARDSON DRIVE SUITE 140 Richardson, TX 75080 |
| Contact | Kenneth L Block |
| Correspondent | Kenneth L Block ARKRAY, INC. 1201 RICHARDSON DRIVE SUITE 140 Richardson, TX 75080 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2009-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015482736279 | K093098 | 000 |
| 00015482145057 | K093098 | 000 |