TITAN GEL HDL CHOLESTEROL KIT— 510(k) K873547
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K873547 for TITAN GEL HDL CHOLESTEROL KIT, Substantially Equivalent on 1987-10-02. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code LBT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Recent devices under product code LBT
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- K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT
- K904035 — REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
- K894366 — REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
More clearances from Helena Laboratories
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- K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Data sourced from openFDA. This site is unofficial and independent of the FDA.