FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LACTEST I
K Number: K971944
·
Decision Dec 17, 1997
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
26
Applicant Total
1
Review Days
204
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Basic Information
- Device Name
- LACTEST I
- K Number
- K971944
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1450
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jwt, Inc.
- Date Received
- May 27, 1997
- Decision Date
- December 17, 1997
- Product Code
- KHP
- 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 |
|---|---|---|---|
| KHP | Acid, Lactic, Enzymatic Method | FDA class 1 | Clinical Chemistry |
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