LDL CHOLESTEROL (AUTOMATED)— 510(k) K022519
Substantially EquivalentJas Diagnostics, Inc.
FDA 510(k) clearance K022519 for LDL CHOLESTEROL (AUTOMATED), Substantially Equivalent on 2002-09-30. Applicant: Jas Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Jas Diagnostics, Inc.
- Product code
- Code JHM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code JHM
view all- K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM
- K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
- K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
- K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
- K983849 — DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
More clearances from Jas Diagnostics, Inc.
view all- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K080623 — CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
- K080618 — DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
- K021671 — JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
- K020454 — CHEMISTRY CALIBRATOR
Recalls naming K022519
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022519.
Data sourced from openFDA. This site is unofficial and independent of the FDA.