FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
K Number: K990654
·
Decision Jun 21, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
4
Review Days
112
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Basic Information
- Device Name
- QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
- K Number
- K990654
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1310
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quantase , Ltd.
- Date Received
- March 1, 1999
- Decision Date
- June 21, 1999
- Product Code
- JIA
- 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 |
|---|---|---|---|
| JIA | Enzymatic Methods, Galactose | FDA class 1 | Clinical Chemistry |
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