FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
K Number: K101746
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
107
Review Days
290
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
- THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
- K Number
- K101746
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corp.
- Date Received
- June 22, 2010
- Decision Date
- April 8, 2011
- Product Code
- LCM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCM), ordered by most recent decision date.
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
FDA 510(k)
FDA Unclassified
·Unknown
SEFRIA PCP Oral Fluid Enzyme Immunoassay
FDA 510(k)
FDA Unclassified
·Unknown
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
FDA 510(k)
FDA Unclassified
·Unknown
Atellica CH Phencyclidine (Pcp)
FDA 510(k)
FDA Unclassified
·Unknown
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
FDA 510(k)
FDA Unclassified
·Unknown
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| 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 |