FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACIFIC HEMOSTASIS REFERENCE EMULSION
K Number: K013397
·
Decision Feb 15, 2002
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
16
Review Days
123
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Basic Information
- Device Name
- PACIFIC HEMOSTASIS REFERENCE EMULSION
- K Number
- K013397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fisher Diagnostics
- Date Received
- October 15, 2001
- Decision Date
- February 15, 2002
- Product Code
- JIX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | Sep 13, 2007 | Substantially Equivalent |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | Jul 18, 2006 | Substantially Equivalent |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | May 10, 2006 | Substantially Equivalent |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | Jan 24, 2005 | Substantially Equivalent |
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | Aug 12, 2004 | Substantially Equivalent |
| 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 |
| 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 |