FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED CEDIA(TM) CORTISOL ASSAY
K Number: K896451
·
Decision Dec 12, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
107
Review Days
33
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
- MODIFIED CEDIA(TM) CORTISOL ASSAY
- K Number
- K896451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Microgenics Corp.
- Date Received
- November 9, 1989
- Decision Date
- December 12, 1989
- Product Code
- CGR
- 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 |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGR), ordered by most recent decision date.
Access Cortisol; DxC 500i Clinical Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IDS Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMULITE/IMMULITE® 1000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMULITE® 2000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CORTISOL ELISA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |