FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
K Number: K052148
·
Decision Nov 9, 2005
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
244
Applicant Total
17
Review Days
93
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Basic Information
- Device Name
- TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
- K Number
- K052148
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Reference Diagnostics, Inc.
- Date Received
- August 8, 2005
- Decision Date
- November 9, 2005
- Product Code
- JIT
- 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | FDA class 2 | Clinical Chemistry |
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Other Clearances by Reference Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053211 | RDI HSFERRITIN KIT | Mar 13, 2006 | Substantially Equivalent |
| K053291 | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 | Mar 13, 2006 | Substantially Equivalent |
| K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 | Sep 30, 2003 | Substantially Equivalent |
| K030772 | RDI EXTENDED RANGE CRP CALIBRATOR SET | Apr 11, 2003 | Substantially Equivalent |
| K021609 | RDI HS CRP KIT | Jun 27, 2002 | Substantially Equivalent |
| K021607 | RDI HS CRP CALIBRATOR SET | Jun 27, 2002 | Substantially Equivalent |
| K000783 | DIRECT TIBC CALIBRATOR | May 4, 2000 | Substantially Equivalent |
| K000781 | DIRECT TIBC KIT | May 2, 2000 | Substantially Equivalent |
| K990216 | MAGNETIC TIBC KIT | Feb 16, 1999 | Substantially Equivalent |
| K984107 | RDI DIRECT LDL CHOLESTEROL TEST | Jan 28, 1999 | Substantially Equivalent |