FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER AMYLASE REAGENT
K Number: K900230
·
Decision Apr 3, 1990
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
98
Applicant Total
51
Review Days
76
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Basic Information
- Device Name
- COULTER AMYLASE REAGENT
- K Number
- K900230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Corp.
- Date Received
- January 17, 1990
- Decision Date
- April 3, 1990
- Product Code
- JFJ
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
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| K973634 | COULTER AC.T DIFF ANALYZER | Oct 29, 1997 | Substantially Equivalent |