FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FEMEXAM TESTCARD
K Number: K962718
·
Decision Feb 7, 1997
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
10
Applicant Total
2
Review Days
210
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Basic Information
- Device Name
- FEMEXAM TESTCARD
- K Number
- K962718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1550
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Litmus Concepts, Inc.
- Date Received
- July 12, 1996
- Decision Date
- February 7, 1997
- Product Code
- CEN
- 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 |
|---|---|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Litmus Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964015 | INDICARD TEST | Jun 19, 1997 | Substantially Equivalent |