FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K Number: K101753
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
48
Applicant Total
107
Review Days
290
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Basic Information
- Device Name
- THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
- K Number
- K101753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- 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
- LAF
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| LAF | Gas Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K123271 | ABBOTT PHENOBARBITAL ASSAY | Apr 26, 2013 | Substantially Equivalent |
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO | Jun 29, 2011 | Substantially Equivalent |
| K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | Apr 8, 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 |
| K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | Apr 8, 2011 | Substantially Equivalent |
| K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY | Apr 8, 2011 | Substantially Equivalent |