FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT STAT CK-MB IMMUNOASSAY
K Number: K041596
·
Decision Jul 21, 2004
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
16
Review Days
37
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Basic Information
- Device Name
- ARCHITECT STAT CK-MB IMMUNOASSAY
- K Number
- K041596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher Diagnostics
- Date Received
- June 14, 2004
- Decision Date
- July 21, 2004
- Product Code
- JHX
- 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 |
|---|---|---|---|
| JHX | Fluorometric Method, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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| K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION | Feb 15, 2002 | Substantially Equivalent |
| K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | Sep 7, 2001 | Substantially Equivalent |
| K850160 | FISHER DIAGNOSTICS LATEST-CRP TEST KIT | Apr 19, 1985 | Substantially Equivalent |