FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNETIC HDL CHOLESTEROL TEST
K Number: K911906
·
Decision Jul 18, 1991
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
17
Review Days
79
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Basic Information
- Device Name
- MAGNETIC HDL CHOLESTEROL TEST
- K Number
- K911906
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Reference Diagnostics, Inc.
- Date Received
- April 30, 1991
- Decision Date
- July 18, 1991
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
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ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
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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 |
| K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET | Nov 9, 2005 | 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 |