FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K Number: K101742
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
107
Review Days
290
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Basic Information
- Device Name
- THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
- K Number
- K101742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corp.
- Date Received
- June 22, 2010
- Decision Date
- April 8, 2011
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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Other Clearances by Microgenics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122766 | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | Aug 20, 2013 | Substantially Equivalent |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Jul 11, 2013 | Substantially Equivalent |
| K123271 | ABBOTT PHENOBARBITAL ASSAY | Apr 26, 2013 | Substantially Equivalent |
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO | Jun 29, 2011 | Substantially Equivalent |
| K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY | Apr 8, 2011 | Substantially Equivalent |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Apr 8, 2011 | Substantially Equivalent |
| K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | Apr 8, 2011 | Substantially Equivalent |
| K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | Apr 8, 2011 | Substantially Equivalent |
| K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | Apr 8, 2011 | Substantially Equivalent |
| K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY | Apr 8, 2011 | Substantially Equivalent |