FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K Number: K862207
·
Decision Jun 17, 1986
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
93
Review Days
7
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Basic Information
- Device Name
- QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
- K Number
- K862207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Quidel Corp.
- Date Received
- June 10, 1986
- Decision Date
- June 17, 1986
- Product Code
- LCX
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Quidel Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Sep 6, 2013 | Substantially Equivalent |
| K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Aug 29, 2013 | Substantially Equivalent |
| K130398 | SOFIA(R) RSV FIA | Aug 13, 2013 | Substantially Equivalent |
| K131166 | SOFIA(R) HCG FIA | Aug 2, 2013 | Substantially Equivalent |
| K131606 | SOFIA INFLUENZA A+B FIA | Jul 5, 2013 | Substantially Equivalent |
| K131619 | QUICKVUE INFLUENZA A+B | Jun 28, 2013 | Substantially Equivalent |
| K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Mar 8, 2013 | Substantially Equivalent |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Mar 8, 2013 | Substantially Equivalent |
| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Mar 15, 2012 | Substantially Equivalent |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Dec 22, 2011 | Substantially Equivalent |