FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINITEST HCG PREGNANCY TEST
K Number: K032563
·
Decision Dec 23, 2003
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
46
Review Days
125
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Basic Information
- Device Name
- CLINITEST HCG PREGNANCY TEST
- K Number
- K032563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- August 20, 2003
- Decision Date
- December 23, 2003
- 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
Other 510(k) clearances with the same product code (JHI), ordered by most recent decision date.
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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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Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
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WUNDER PREGNANCY TEST
FDA 510(k)
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