FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL KIT
K Number: K771067
·
Decision Jul 21, 1977
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
15
Review Days
38
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
- CHOLESTEROL KIT
- K Number
- K771067
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Environmental Chemical Specialties
- Date Received
- June 13, 1977
- Decision Date
- July 21, 1977
- 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 Environmental Chemical Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K812635 | ANEMIA CONTROL | Oct 2, 1981 | Substantially Equivalent |
| K811810 | URIC ACID TEST | Jul 15, 1981 | Substantially Equivalent |
| K811809 | ANTI-ARRHYTHMIC CONTROL LEVELS I & II | Jul 10, 1981 | Substantially Equivalent |
| K811811 | TDM ANTI-CONVULSANT CONTROL LEVELS I-II | Jul 10, 1981 | Substantially Equivalent |
| K803089 | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) | Jan 2, 1981 | Substantially Equivalent |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | Sep 26, 1980 | Substantially Equivalent |
| K801854 | SPINAL FLUID CONTROL(HUMAN) | Sep 16, 1980 | Substantially Equivalent |
| K801061 | TOTAL PROTEIN TEST | Jul 21, 1980 | Substantially Equivalent |
| K792374 | QUANTITATIVE CONTROL URINE I (HUMAN) | Dec 6, 1979 | Substantially Equivalent |
| K792376 | QUANTITATIVE CONTROL URINE II (HUMAN) | Dec 6, 1979 | Substantially Equivalent |