DS30 HCY HOMOCYSTEINE ASSAY KIT
FDA 510(k) clearance K982003 · decided 1999-02-11
Clearance details
- K-number
- K982003
- Device name
- DS30 HCY HOMOCYSTEINE ASSAY KIT
- Applicant
- Drew Scientific , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-08
- Decision date
- 1999-02-11
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- LPS
- Device class
- 2
- Regulation number
- 862.1377
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Barrow In Furness, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Drew Scientific
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.