FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COULTER GAMMA-GT (GGT) REAGENT
K Number: K901264
·
Decision Apr 16, 1990
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
51
Applicant Total
51
Review Days
31
Basic Information
- Device Name
- COULTER GAMMA-GT (GGT) REAGENT
- K Number
- K901264
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1360
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- COULTER CORP.
- Date Received
- March 16, 1990
- Decision Date
- April 16, 1990
- Product Code
- JQB
- 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 |
|---|---|---|---|
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | FDA class 1 | Clinical Chemistry |
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