FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALBUMIN REAGENT FOR DEMAND ANALYZER
K Number: K844330
·
Decision Jan 3, 1985
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
21
Review Days
57
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Basic Information
- Device Name
- ALBUMIN REAGENT FOR DEMAND ANALYZER
- K Number
- K844330
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biomedical Methods, Inc.
- Date Received
- November 7, 1984
- Decision Date
- January 3, 1985
- 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 |
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Other Clearances by Advanced Biomedical Methods, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945353 | CLARIT(TM) | Dec 9, 1994 | Substantially Equivalent |
| K880949 | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER | Apr 5, 1988 | Substantially Equivalent |
| K864866 | RESUBMISSION OF THE KLEERZIT REAGENT | Mar 16, 1987 | Substantially Equivalent |
| K852784 | ALKALINE PHOSPHATASE | Jul 22, 1985 | Substantially Equivalent |
| K852783 | SGOT/ALT REAGENT | Jul 22, 1985 | Substantially Equivalent |
| K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | May 29, 1985 | Substantially Equivalent |
| K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850381 | MAGNESIUM REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |