Product code MRR— Clinical Chemistry
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
- Classification name
- System, Test, Low Density, Lipoprotein
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Total cleared
- 31
- First cleared
- Most recent
Market context for product code MRR
FDA has cleared devices under product code MRR between 1990 and 2024, filed by 26 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2024
- 2023
- 2017
- 2009
- 2008
- 2005
- 2004
- 2002
- 2001
- 2000
- 1999
- 1998
- 1996
- 1995
- 1993
Top applicants under product code MRR
Recent clearances under product code MRR
- 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
- K063841 — NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
- K051121 — DIRECT LDL CHOLESTEROL, MODEL L530-60H
- K043264 — LDL-EX SEIKEN ASSAY KIT
- K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
- K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
- K040693 — PTS PANELS LDL CHOLESTEROL TEST STRIPS
- K022772 — RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
- K020724 — DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
- K020575 — ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
- K014103 — SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
- K012287 — MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
- K993741 — EZ LDL CHOLESTEROL TEST SYSTEM
- K992766 — N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
- K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
- K984107 — RDI DIRECT LDL CHOLESTEROL TEST
- K982848 — COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
- K982271 — WAKO DIRECT LDL-C
- K982529 — RANDOX DIRECT LDL CHOLESTEROL
- K981303 — DIRECT LDL
- K981978 — AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
- K964063 — RDI LDL PRECIPITATION REAGENT
- K964064 — RDI LIPIDIRECT MAGNETIC LDL REAGENT
- K955904 — EKTACHEM DT LDL CHOLESTEROL KIT
- K943150 — DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
- K924674 — DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
- K893740 — LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
Data sourced from openFDA. This site is unofficial and independent of the FDA.