FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ZAP HCG TEST, MODEL 8001
K Number: K033297
·
Decision Mar 18, 2004
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
374
Applicant Total
1
Review Days
156
Basic Information
- Device Name
- ZAP HCG TEST, MODEL 8001
- K Number
- K033297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ZBX CORPORATION
- Date Received
- October 14, 2003
- Decision Date
- March 18, 2004
- 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.
Innovita HCG Pregnancy Rapid Combo Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alltest Pregnancy Rapid Combo Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica IM Total hCG (ThCG)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WUNDER PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry