FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K Number: K052407
·
Decision Jul 18, 2006
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
16
Review Days
320
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K Number
- K052407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher Diagnostics
- Date Received
- September 1, 2005
- Decision Date
- July 18, 2006
- Product Code
- JZO
- 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 |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZO), ordered by most recent decision date.
ADVIA Centaur Anti-Thyroid Peroxidase II
FDA 510(k)
FDA Class 2
·Immunology
Access TPO Antibody
FDA 510(k)
FDA Class 2
·Immunology
Access Thyroglobulin Antibody II
FDA 510(k)
FDA Class 2
·Immunology
Elecsys Anti-Tg
FDA 510(k)
FDA Class 2
·Immunology
Elecsys Anti-TSHR
FDA 510(k)
FDA Class 2
·Immunology
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Fisher Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls | Jun 1, 2017 | Substantially Equivalent |
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | Sep 13, 2007 | 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 |
| 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 |