The following data is part of a premarket notification filed by Artron Laboratories, Inc. with the FDA for Arton One-step Hcg Urinary Pregnancy Test (strip), (cassette), (midstream).
| Device ID | K060019 |
| 510k Number | K060019 |
| Device Name: | ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ARTRON LABORATORIES, INC. 3938 NORTH FRASER WAY Burnaby, British Columbia, CA V5j 5h6 |
| Contact | Jerry Zheng |
| Correspondent | Jerry Zheng ARTRON LABORATORIES, INC. 3938 NORTH FRASER WAY Burnaby, British Columbia, CA V5j 5h6 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-04 |
| Decision Date | 2006-02-17 |