The following data is part of a premarket notification filed by Drew Scientific Ltd. with the FDA for Ds30 Hcy Homocysteine Assay Kit.
| Device ID | K982003 |
| 510k Number | K982003 |
| Device Name: | DS30 HCY HOMOCYSTEINE ASSAY KIT |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | DREW SCIENTIFIC LTD. PARK RD.,TELEMETER BLDG. Barrow In Furness, GB La 14 4qr |
| Contact | Andrew Kenney |
| Correspondent | Andrew Kenney DREW SCIENTIFIC LTD. PARK RD.,TELEMETER BLDG. Barrow In Furness, GB La 14 4qr |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-08 |
| Decision Date | 1999-02-11 |