FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
K Number: K952741
·
Decision Aug 17, 1995
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
57
Review Days
62
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Basic Information
- Device Name
- TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
- K Number
- K952741
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Diagnostic Technologies, Inc.
- Date Received
- June 16, 1995
- Decision Date
- August 17, 1995
- Product Code
- CDT
- 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
| K062229 | CTC WORKSTATION, MODEL 2200 | Sep 11, 2006 | Substantially Equivalent |
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| K963106 | CHROMOLIZE PAI-1 KIT | Nov 18, 1996 | Substantially Equivalent |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | Aug 14, 1996 | Substantially Equivalent |
| K962489 | CHROMOLIZE TPA ASSAY KIT | Jul 31, 1996 | Substantially Equivalent |
| K960438 | TINTELIZE PAI-1 KIT | Jun 5, 1996 | Substantially Equivalent |
| K961724 | U-DOA CONTROLS | Jun 3, 1996 | Substantially Equivalent |
| K961370 | LA POSITIVE CONTROL PLASMA | May 24, 1996 | Substantially Equivalent |
| K955115 | VENOM TIEM REAGENT | Apr 3, 1996 | Substantially Equivalent |
| K955738 | BIOCLOT PROTEIN S | Feb 29, 1996 | Substantially Equivalent |