FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
K Number: K071706
·
Decision Dec 20, 2007
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
36
Review Days
182
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
- ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
- K Number
- K071706
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Data, Inc.
- Date Received
- June 21, 2007
- Decision Date
- December 20, 2007
- 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 Clinical Data, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Feb 9, 2006 | Substantially Equivalent |
| K033983 | VITALAB IRON REAGENT | May 21, 2004 | Substantially Equivalent |
| K040631 | VITALAB DIRECT BILIRUBIN REAGENT | Mar 18, 2004 | Substantially Equivalent |
| K040534 | VITALAB AMYLASE REAGENT | Mar 11, 2004 | Substantially Equivalent |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Mar 10, 2004 | Substantially Equivalent |
| K040508 | VITALAB MAGNESIUM REAGENT | Mar 8, 2004 | Substantially Equivalent |
| K040467 | VITALAB URIC ACID REAGENT | Mar 8, 2004 | Substantially Equivalent |
| K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT | Nov 3, 2003 | Substantially Equivalent |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | Jul 15, 2003 | Substantially Equivalent |
| K863904 | DISPOSABLE ECG MONITORING ELECTRODE | Jan 6, 1987 | Substantially Equivalent |