FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
K Number: K961828
·
Decision Jun 11, 1996
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
318
Review Days
29
Basic Information
- Device Name
- LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
- K Number
- K961828
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIO-RAD
- Date Received
- May 13, 1996
- Decision Date
- June 11, 1996
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
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LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
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·Clinical Chemistry
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by BIO-RAD
| K Number | Device Name | ||
|---|---|---|---|
| K122187 | VRESELECT CULTURE MEDIUM | Nov 6, 2012 | Substantially Equivalent |
| K103684 | VRESELECT CULTURE MEDIUM | Oct 21, 2011 | Substantially Equivalent |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | Jan 13, 2011 | Substantially Equivalent |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Oct 29, 2010 | Substantially Equivalent |
| K081362 | PLATELIA LYME IGM | Jun 26, 2008 | Substantially Equivalent |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Jun 13, 2008 | Substantially Equivalent |
| K080012 | PLATELIA LYME IGG ASSAY | May 8, 2008 | Substantially Equivalent |
| K070361 | MRSASELECT | Sep 13, 2007 | Substantially Equivalent |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | Jun 2, 2006 | Substantially Equivalent |
| K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | Nov 9, 2005 | Substantially Equivalent |