FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
K Number: K110616
·
Decision Jun 29, 2011
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
107
Review Days
118
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Basic Information
- Device Name
- THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
- K Number
- K110616
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corp.
- Date Received
- March 3, 2011
- Decision Date
- June 29, 2011
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Microgenics Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Jul 11, 2013 | Substantially Equivalent |
| K123271 | ABBOTT PHENOBARBITAL ASSAY | Apr 26, 2013 | 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 |
| 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 |