510(k) Premarket Notification Database
Device Classification Name |
kit, test, pregnancy, hcg, over the counter
|
510(k) Number | K990262 |
Device Name | CLEARPLAN EASY HOME PREGNANCY TEST |
Applicant |
UNIPATH LTD.
|
priory business park |
bedford,
|
|
Contact | louise roberts |
Regulation Number | 862.1155 |
Classification Product Code |
|
Date Received | 01/27/1999 |
Decision Date | 04/07/1999 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Clinical Chemistry
|
Statement/Summary/Purged Status |
Statement only
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|