FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALCIUM REAGENT FOR DEMAND ANALYZER
K Number: K844241
·
Decision Jan 3, 1985
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
98
Applicant Total
21
Review Days
63
Basic Information
- Device Name
- CALCIUM REAGENT FOR DEMAND ANALYZER
- K Number
- K844241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ADVANCED BIOMEDICAL METHODS, INC.
- Date Received
- November 1, 1984
- Decision Date
- January 3, 1985
- Product Code
- CIC
- 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 |
|---|---|---|---|
| CIC | Cresolphthalein Complexone, Calcium | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
| K945353 | CLARIT(TM) | Dec 9, 1994 | Substantially Equivalent |
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| 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 |
| K850381 | MAGNESIUM REAGENT 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 |