FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECSYS HCG TEST SYSTEM
K Number: K002148
·
Decision Aug 22, 2000
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
264
Review Days
36
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
- ELECSYS HCG TEST SYSTEM
- K Number
- K002148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- July 17, 2000
- Decision Date
- August 22, 2000
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHA), ordered by most recent decision date.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Total ßhCG (5th IS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Roche Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130138 | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM | Mar 15, 2013 | Substantially Equivalent |
| K101365 | ELECSYS CA 19-9 CALCHECK 5 | Oct 5, 2010 | Substantially Equivalent |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Sep 9, 2010 | Substantially Equivalent |
| K101196 | ACCU-CHEK ULTRFLEX INFUSION SET | Aug 27, 2010 | Substantially Equivalent |
| K093664 | AMPHETAMINES II ASSAY | Jul 28, 2010 | Substantially Equivalent |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Jun 11, 2010 | Substantially Equivalent |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Apr 23, 2010 | Substantially Equivalent |
| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Mar 19, 2010 | Substantially Equivalent |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Mar 5, 2010 | Substantially Equivalent |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Mar 4, 2010 | Substantially Equivalent |