FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CLEARPLAN EASY HOME PREGNANCY TEST
K Number: K990262
·
Decision Apr 7, 1999
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
223
Applicant Total
73
Review Days
70
Basic Information
- Device Name
- CLEARPLAN EASY HOME PREGNANCY TEST
- K Number
- K990262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- UNIPATH LTD.
- Date Received
- January 27, 1999
- Decision Date
- April 7, 1999
- 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.
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
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Shinetell Digital Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by UNIPATH LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST | Jul 3, 2006 | Substantially Equivalent |
| K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | May 25, 2006 | Substantially Equivalent |
| K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | Dec 6, 2005 | Substantially Equivalent |
| K050930 | E.P.T. CERTAINTY PREGNANCY TEST | May 12, 2005 | Substantially Equivalent |
| K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | Sep 10, 2004 | Substantially Equivalent |
| K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST | Jun 8, 2004 | Substantially Equivalent |
| K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST | Mar 8, 2004 | Substantially Equivalent |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | Mar 8, 2004 | Substantially Equivalent |
| K033658 | E.P.T. PREGNANCY TEST | Jan 16, 2004 | Substantially Equivalent |
| K032939 | EPT CERTAINTY PREGNANCY TEST | Oct 20, 2003 | Substantially Equivalent |