FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
K Number: K990223
·
Decision Feb 24, 1999
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
5
Applicant Total
73
Review Days
30
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Basic Information
- Device Name
- MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
- K Number
- K990223
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unipath , Ltd.
- Date Received
- January 25, 1999
- Decision Date
- February 24, 1999
- Product Code
- NGE
- 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 |
|---|---|---|---|
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |