Device Classification Name |
newborn screening specimen collection paper
|
510(k) Number |
K932661 |
Device Name |
WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 |
Applicant |
WHATMAN SPECIALTY PRODUCTS, INC. |
6 JUST RD. |
FAIRFIELD,
NJ
07004
|
|
Applicant Contact |
RICHARD J COPPOLA |
Correspondent |
WHATMAN SPECIALTY PRODUCTS, INC. |
6 JUST RD. |
FAIRFIELD,
NJ
07004
|
|
Correspondent Contact |
RICHARD J COPPOLA |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 06/02/1993 |
Decision Date | 04/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|