HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT— 510(k) K011689
Substantially EquivalentCatch, Inc.
FDA 510(k) clearance K011689 for HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT, Substantially Equivalent on 2001-07-25. Applicant: Catch, Inc.. Device class: 2.
Clearance details
- Applicant
- Catch, Inc.
- 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
- Longview, WA, 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.