FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRI COTININE EIA ASSAY
K Number: K030649
·
Decision May 22, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
2
Applicant Total
107
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DRI COTININE EIA ASSAY
- K Number
- K030649
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corp.
- Date Received
- February 28, 2003
- Decision Date
- May 22, 2003
- Product Code
- MRS
- 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 |
|---|---|---|---|
| MRS | Test System, Nicotine, Cotinine, Metabolites | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRS), ordered by most recent decision date.
NICALERT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
NICCHECK I
FDA 510(k)
FDA Class 1
·Clinical Toxicology
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 |
| 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 |