FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K Number: K854179
·
Decision Nov 25, 1985
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
36
Review Days
41
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
- IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
- K Number
- K854179
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data, Inc.
- Date Received
- October 15, 1985
- Decision Date
- November 25, 1985
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHH), ordered by most recent decision date.
Lipids
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Cholesterol2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS XT Chemistry Products TRIG-CHOL Slides
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Extended Lipid Panel Assay
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mission Lipid Panel Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Clinical Data, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | Dec 20, 2007 | Substantially Equivalent |
| 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 |