FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K Number: K083391
·
Decision May 21, 2009
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
37
Review Days
185
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Basic Information
- Device Name
- THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
- K Number
- K083391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Hybrids, Inc.
- Date Received
- November 17, 2008
- Decision Date
- May 21, 2009
- 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 |
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Other Clearances by Diagnostic Hybrids, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | May 13, 2014 | Unknown |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | May 18, 2010 | Substantially Equivalent |
| K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | Dec 23, 2009 | Substantially Equivalent |
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | Dec 4, 2009 | Substantially Equivalent |
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | Oct 21, 2009 | Substantially Equivalent |
| K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | Sep 11, 2009 | Substantially Equivalent |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Aug 28, 2009 | Substantially Equivalent |
| K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | Aug 28, 2009 | Substantially Equivalent |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | Mar 6, 2009 | Substantially Equivalent |
| K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | Dec 23, 2008 | Substantially Equivalent |