ABBOTT AXSYM HOMOCYSTEINE— 510(k) K992858
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K992858 for ABBOTT AXSYM HOMOCYSTEINE, Substantially Equivalent on 1999-10-25. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code LPS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
Recent devices under product code LPS
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- K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT
- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K113793 — HOMOCYSTEINE TEST
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
More clearances from Abbott Laboratories
view allData sourced from openFDA. This site is unofficial and independent of the FDA.