Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K050328 |
Device Name |
PREGNANCY-SKREEN |
Applicant |
BIOCHEMICAL DIAGNOSTIC, INC. |
180 HEARTLAND BLVD. |
BRENTWOOD,
NY
11717
|
|
Applicant Contact |
ALLEN PANETZ |
Correspondent |
BIOCHEMICAL DIAGNOSTIC, INC. |
180 HEARTLAND BLVD. |
BRENTWOOD,
NY
11717
|
|
Correspondent Contact |
ALLEN PANETZ |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 02/09/2005 |
Decision Date | 03/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|