MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS— 510(k) K013662
Substantially EquivalentQuantimetrix Corp.
FDA 510(k) clearance K013662 for MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS, Substantially Equivalent on 2002-03-08. Applicant: Quantimetrix Corp.. Device class: 1.
Clearance details
- Applicant
- Quantimetrix Corp.
- Product code
- Code JHO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redondo Beach, CA, US
Recent devices under product code JHO
view all- K022333 — SPIFE LIPPOROTEIN-12, MODEL 3344
- K022053 — HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
- K012789 — MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
- K013466 — SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
- K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS
More clearances from Quantimetrix Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.