The following data is part of a premarket notification filed by Quantech Ltd. with the FDA for Quantech Total B-hcg Assay.
| Device ID | K990258 |
| 510k Number | K990258 |
| Device Name: | QUANTECH TOTAL B-HCG ASSAY |
| Classification | Test, Immunoassay, Biosensor, Hcg |
| Applicant | QUANTECH LTD. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin Hellen |
| Correspondent | Robin Hellen QUANTECH LTD. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | NAL |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-27 |
| Decision Date | 1999-12-21 |
| Summary: | summary |