FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K Number: K053157
·
Decision Dec 9, 2005
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
343
Review Days
25
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
- K Number
- K053157
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- November 14, 2005
- Decision Date
- December 9, 2005
- Product Code
- LBS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBS), ordered by most recent decision date.
HDL-Cholesterol Gen.4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Direct HDL Cholesterol (HDL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Dade Behring, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dec 20, 2010 | Substantially Equivalent |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | Jul 28, 2008 | Substantially Equivalent |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Jul 21, 2008 | Substantially Equivalent |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Jun 25, 2008 | Substantially Equivalent |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Jun 4, 2008 | Substantially Equivalent |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | Mar 13, 2008 | Substantially Equivalent |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | Feb 26, 2008 | Substantially Equivalent |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Feb 21, 2008 | Substantially Equivalent |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Jan 3, 2008 | Substantially Equivalent |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dec 21, 2007 | Substantially Equivalent |