FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS STANDARDS FOR ALBUMIN
K Number: K823575
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
49
Review Days
32
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
- COBAS STANDARDS FOR ALBUMIN
- K Number
- K823575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hoffmann-La Roche, Inc.
- Date Received
- December 6, 1982
- Decision Date
- January 7, 1983
- Product Code
- CIX
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIX), ordered by most recent decision date.
Core Metabolic
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Albumin BCG2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS XT Chemistry Products ALB-TP Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Hoffmann-La Roche, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850727 | BHCG-ROCHE EIA | Jun 25, 1985 | Substantially Equivalent |
| K831694 | RENAK | Jul 19, 1983 | Substantially Equivalent |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | Mar 24, 1983 | Substantially Equivalent |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Mar 24, 1983 | Substantially Equivalent |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Mar 24, 1983 | Substantially Equivalent |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Mar 24, 1983 | Substantially Equivalent |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Mar 24, 1983 | Substantially Equivalent |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Mar 24, 1983 | Substantially Equivalent |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Mar 10, 1983 | Substantially Equivalent |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | Jan 7, 1983 | Substantially Equivalent |