FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
K Number: K945280
·
Decision Mar 9, 1995
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
28
Review Days
132
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Basic Information
- Device Name
- DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
- K Number
- K945280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dupont Medical Products
- Date Received
- October 28, 1994
- Decision Date
- March 9, 1995
- Product Code
- DCK
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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Other Clearances by Dupont Medical Products
| K Number | Device Name | ||
|---|---|---|---|
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| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Jul 20, 1995 | Substantially Equivalent |
| K952412 | DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL | Jun 23, 1995 | Substantially Equivalent |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | Dec 28, 1994 | Substantially Equivalent |
| K941050 | DUPONT ACA STAR | Nov 10, 1994 | Substantially Equivalent |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | Oct 20, 1994 | Substantially Equivalent |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | Oct 3, 1994 | Substantially Equivalent |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | Sep 9, 1994 | Substantially Equivalent |
| K942241 | DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN | Aug 18, 1994 | Substantially Equivalent |