FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE-STEP DIPSTICK PREGNANCY TEST
K Number: K964536
·
Decision Feb 11, 1997
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
51
Review Days
91
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Basic Information
- Device Name
- ONE-STEP DIPSTICK PREGNANCY TEST
- K Number
- K964536
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Teco Diagnostics
- Date Received
- November 12, 1996
- Decision Date
- February 11, 1997
- Product Code
- JHI
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
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