FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICK CARD HCG ONE STEP PREGNANCY TEST
K Number: K973570
·
Decision Oct 31, 1997
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
47
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QUICK CARD HCG ONE STEP PREGNANCY TEST
- K Number
- K973570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech
- Date Received
- September 19, 1997
- Decision Date
- October 31, 1997
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCX), ordered by most recent decision date.
MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Shinetell PlusTM Digital Early Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Phamatech
| K Number | Device Name | ||
|---|---|---|---|
| K041578 | QUICKSCREEN, MODELS 9177X AND 9178X | Sep 10, 2004 | Substantially Equivalent |
| K030447 | AT HOME DRUG CUP, MODEL 9150X | Apr 14, 2003 | Substantially Equivalent |
| K010833 | AT WORK DRUG TEST, MODEL 9177T AWT | Apr 11, 2001 | Substantially Equivalent |
| K010836 | AT WORK DRUG TEST, MODEL 9147T AWT | Apr 11, 2001 | Substantially Equivalent |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | Apr 5, 2001 | Substantially Equivalent |
| K010653 | AT HOME DRUG TEST, MODEL 9068 T | Apr 5, 2001 | Substantially Equivalent |
| K010655 | AT HOME DRUG TESTT, MODEL 9150 T | Apr 5, 2001 | Substantially Equivalent |
| K010645 | AT HOME DRUG TEST, MODEL 9063 T | Mar 30, 2001 | Substantially Equivalent |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | Mar 30, 2001 | Substantially Equivalent |
| K010651 | AT HOME DRUG TEST, MODEL 9133 T | Mar 30, 2001 | Substantially Equivalent |