FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTRX FEMALE FERTILITY TEST
K Number: K070484
·
Decision Oct 22, 2007
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
1
Applicant Total
4
Review Days
244
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Basic Information
- Device Name
- QUANTRX FEMALE FERTILITY TEST
- K Number
- K070484
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quantrx Biomedical Corporation
- Date Received
- February 20, 2007
- Decision Date
- October 22, 2007
- Product Code
- NGA
- 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 |
|---|---|---|---|
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NGA), ordered by most recent decision date.
View allOther Clearances by Quantrx Biomedical Corporation
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| K080431 | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 | Jan 8, 2009 | Substantially Equivalent |
| K080455 | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 | Dec 31, 2008 | Substantially Equivalent |