The following data is part of a premarket notification filed by Zbx Corporation with the FDA for Zap Hcg Test, Model 8001.
| Device ID | K033297 |
| 510k Number | K033297 |
| Device Name: | ZAP HCG TEST, MODEL 8001 |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ZBX CORPORATION 42 LAIRD DRIVE Toronto, CA M4g 3t2 |
| Contact | Tracy Yang |
| Correspondent | Tracy Yang ZBX CORPORATION 42 LAIRD DRIVE Toronto, CA M4g 3t2 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2004-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858022006216 | K033297 | 000 |
| 00858022006209 | K033297 | 000 |
| 00858022006193 | K033297 | 000 |