ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS— 510(k) K991733
Substantially EquivalentSchiapparelli Biosystems, Inc.
FDA 510(k) clearance K991733 for ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS, Substantially Equivalent on 1999-07-13. Applicant: Schiapparelli Biosystems, Inc.. Device class: 1.
Clearance details
- Applicant
- Schiapparelli Biosystems, Inc.
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, NJ, US
Recent devices under product code MRR
view all- K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
- K210801 — AXINON® LDL-p Test System
- K161691 — Direct LDL Cholesterol (LDL)
- K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
- K090734 — EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
More clearances from Schiapparelli Biosystems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.