FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
K Number: DEN140001
·
Decision Aug 20, 2014
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
11
Review Days
65
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Basic Information
- Device Name
- ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
- K Number
- DEN140001
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.5670
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- Kronus Market Development Associates, Inc.
- Date Received
- June 16, 2014
- Decision Date
- August 20, 2014
- Product Code
- PHF
- 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 |
|---|---|---|---|
| PHF | Zinc Transporter 8 Auto-Antibody | FDA class 2 | Immunology |
Other Clearances by Kronus Market Development Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | Dec 20, 2012 | Substantially Equivalent |
| K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT | May 30, 2012 | Substantially Equivalent |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | Jun 17, 2008 | Substantially Equivalent |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | May 22, 2008 | Substantially Equivalent |
| K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | Apr 10, 2008 | Substantially Equivalent |
| K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | Nov 7, 2007 | Substantially Equivalent |
| K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | Jul 13, 2007 | Substantially Equivalent |
| K051061 | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT | Nov 4, 2005 | Substantially Equivalent |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | Dec 17, 2004 | Substantially Equivalent |
| K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | Sep 10, 2003 | Substantially Equivalent |