FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CRP LIPID REAGENT TEST PACK
K Number: K905648
·
Decision Mar 6, 1991
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
10
Review Days
79
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
- CRP LIPID REAGENT TEST PACK
- K Number
- K905648
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cirrus Diagnostics, Inc.
- Date Received
- December 17, 1990
- Decision Date
- March 6, 1991
- 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 Cirrus Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921704 | IMMULITE(R) FSH | Jun 9, 1992 | Substantially Equivalent |
| K920411 | IMMULITE HLH | Mar 11, 1992 | Substantially Equivalent |
| K914833 | IMMULITE DIGOXIN | Nov 22, 1991 | Substantially Equivalent |
| K911796 | IMMULITE(TM) HCG | Jun 20, 1991 | Substantially Equivalent |
| K910677 | IMMULITE(TM) T-UPTAKE | Apr 29, 1991 | Substantially Equivalent |
| K910261 | IMMULITE(TM) TOTAL T4 | Apr 16, 1991 | Substantially Equivalent |
| K905214 | IMMULITE (TM) TOTAL T3 | Feb 1, 1991 | Substantially Equivalent |
| K905769 | IMMULITE HS-TSH | Jan 31, 1991 | Substantially Equivalent |
| K905215 | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER | Jan 11, 1991 | Substantially Equivalent |