Device Classification Name |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
510(k) Number |
K030849 |
Device Name |
AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 |
Applicant |
N-DIA, INC. |
30 E. 20TH ST., STE. 501 |
NEW YORK,
NY
10003
|
|
Applicant Contact |
MICHAEL FRIEDMAN |
Correspondent |
N-DIA, INC. |
30 E. 20TH ST., STE. 501 |
NEW YORK,
NY
10003
|
|
Correspondent Contact |
MICHAEL FRIEDMAN |
Regulation Number | 862.1660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/17/2003 |
Decision Date | 02/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|