FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
DIASTAT ANTI-THYROID PEROXIDASE KIT
K Number: K951487
·
Decision Jun 30, 1995
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
27
Review Days
91
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Basic Information
- Device Name
- DIASTAT ANTI-THYROID PEROXIDASE KIT
- K Number
- K951487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shield Diagnostics, Ltd.
- Date Received
- March 31, 1995
- Decision Date
- June 30, 1995
- 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 Shield Diagnostics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | Apr 17, 2000 | Substantially Equivalent |
| K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY | Oct 15, 1998 | Substantially Equivalent |
| K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY | Aug 21, 1998 | Substantially Equivalent |
| K972981 | SHIELD HELICO-G2 ELISA KIT | Mar 17, 1998 | Substantially Equivalent |
| K962825 | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY | Nov 15, 1996 | Substantially Equivalent |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Nov 7, 1996 | Substantially Equivalent |
| K961515 | QUANTASE PHENYLALANINE ASSAY | Jun 12, 1996 | Substantially Equivalent |
| K955303 | DIASTAT ANTI-CARDIOLIPIN KIT | May 30, 1996 | Substantially Equivalent |
| K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | Jun 30, 1995 | Substantially Equivalent |
| K943630 | DIASTAT ANTI-MPO (PANCA) KIT | Mar 6, 1995 | Substantially Equivalent |