FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QTEST(TM) PREGNANCY
K Number: K882086
·
Decision Jul 28, 1988
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
93
Review Days
71
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Basic Information
- Device Name
- QTEST(TM) PREGNANCY
- K Number
- K882086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Quidel Corp.
- Date Received
- May 18, 1988
- Decision Date
- July 28, 1988
- 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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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
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