FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
CLEARPLAN EASY
K Number: K894579
·
Decision Oct 12, 1989
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
73
Review Days
80
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Basic Information
- Device Name
- CLEARPLAN EASY
- K Number
- K894579
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Unipath , Ltd.
- Date Received
- July 24, 1989
- Decision Date
- October 12, 1989
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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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 |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | Mar 8, 2004 | Substantially Equivalent |
| K040329 | MODIFICATION TO E.P.T. 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 |