FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCESSORY HDL CHOLESTEROL REAGENT SET
K Number: K780638
·
Decision May 26, 1978
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
26
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
- ACCESSORY HDL CHOLESTEROL REAGENT SET
- K Number
- K780638
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- The Dow Chemical Co.
- Date Received
- April 18, 1978
- Decision Date
- May 26, 1978
- 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 The Dow Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K823474 | ENZYMATIC GLUCOSE DETERMINATION | Dec 30, 1982 | Substantially Equivalent |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | Aug 5, 1982 | Substantially Equivalent |
| K821536 | DOWFLOW ALT-UV DETERMINATION | Jun 14, 1982 | Substantially Equivalent |
| K821315 | DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM | May 24, 1982 | Substantially Equivalent |
| K820675 | BILIRUBIN(TOTAL) DETERMINATION CTMS | Apr 1, 1982 | Substantially Equivalent |
| K820714 | DOW BILIRUBIN(DIRECT) DETERMINATION | Apr 1, 1982 | Substantially Equivalent |
| K812777 | DIRECT IRON REAGENT SET | Oct 19, 1981 | Substantially Equivalent |
| K811806 | QUICK-CHEM COLORIMETER | Jul 15, 1981 | Substantially Equivalent |
| K810861 | CREATINE KINASE MB ISOENZYME IMMUNO UV | Apr 14, 1981 | Substantially Equivalent |
| K810727 | AST-UV (PLP-ACTIVATED) DETERMINATION | Mar 31, 1981 | Substantially Equivalent |