FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
K Number: K031534
·
Decision Jul 30, 2003
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
19
Review Days
75
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Basic Information
- Device Name
- CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
- K Number
- K031534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scantibodies Laboratory, Inc.
- Date Received
- May 16, 2003
- Decision Date
- July 30, 2003
- Product Code
- CEW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Scantibodies Laboratory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | Aug 30, 2006 | Substantially Equivalent |
| K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 | Mar 1, 2006 | Substantially Equivalent |
| K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | Feb 27, 2006 | Substantially Equivalent |
| K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 | Oct 18, 2005 | Substantially Equivalent |
| K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 | Sep 9, 2005 | Substantially Equivalent |
| K051150 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | Jul 26, 2005 | Substantially Equivalent |
| K051141 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 | Jul 26, 2005 | Substantially Equivalent |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | May 20, 2005 | Substantially Equivalent |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | Jun 3, 2002 | Substantially Equivalent |
| K004038 | TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 | Apr 30, 2001 | Substantially Equivalent |