FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EASY-TEST LACTIC ACID (LA)
K Number: K880787
·
Decision Mar 15, 1988
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
26
Applicant Total
14
Review Days
18
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Basic Information
- Device Name
- EASY-TEST LACTIC ACID (LA)
- K Number
- K880787
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1450
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Systems
- Date Received
- February 26, 1988
- Decision Date
- March 15, 1988
- 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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