FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM CYCLOSPORINE
K Number: K040761
·
Decision Apr 30, 2004
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
8
Applicant Total
6
Review Days
36
Basic Information
- Device Name
- AXSYM CYCLOSPORINE
- K Number
- K040761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1235
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories, Inc.
- Date Received
- March 25, 2004
- Decision Date
- April 30, 2004
- Product Code
- MKW
- 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 |
|---|---|---|---|
| MKW | Cyclosporine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Abbott Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090358 | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 | Aug 6, 2009 | Substantially Equivalent |
| K061193 | CREATININE | Jun 23, 2006 | Substantially Equivalent |
| K051213 | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS | May 27, 2005 | Substantially Equivalent |
| K040954 | FOX PLUS PTA CATHETER | May 11, 2004 | Substantially Equivalent |
| K023062 | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT | Sep 30, 2002 | Substantially Equivalent |