FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL TEST
K Number: K923733
·
Decision Oct 26, 1992
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
288
Review Days
91
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 TEST
- K Number
- K923733
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Em Diagnostic Systems, Inc.
- Date Received
- July 27, 1992
- Decision Date
- October 26, 1992
- 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 Em Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | Jan 27, 1994 | Substantially Equivalent |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Jan 13, 1994 | Substantially Equivalent |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935179 | EMDS ALBUMIN (ALB) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Dec 16, 1993 | Substantially Equivalent |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Dec 16, 1993 | Substantially Equivalent |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | Dec 16, 1993 | Substantially Equivalent |
| K935175 | LACTATE DEHYDROGENASE (LD) | Dec 16, 1993 | Substantially Equivalent |
| K935176 | IRON TEST | Dec 16, 1993 | Substantially Equivalent |
| K935183 | EMDS MAGNESIUM (MG) TEST | Dec 9, 1993 | Substantially Equivalent |