FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT STAT MYO IMMUNOASSAY
K Number: K042924
·
Decision Jan 24, 2005
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
45
Applicant Total
16
Review Days
94
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Basic Information
- Device Name
- ARCHITECT STAT MYO IMMUNOASSAY
- K Number
- K042924
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5680
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher Diagnostics
- Date Received
- October 22, 2004
- Decision Date
- January 24, 2005
- Product Code
- DDR
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | Sep 13, 2007 | Substantially Equivalent |
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| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | Jul 21, 2004 | Substantially Equivalent |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | Dec 9, 2002 | Substantially Equivalent |
| 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 |