Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K013397 |
Device Name |
PACIFIC HEMOSTASIS REFERENCE EMULSION |
Applicant |
FISHER DIAGNOSTICS |
8365 VALLEY PIKE |
MIDDLETOWN,
VA
22645 -0307
|
|
Applicant Contact |
JERALD P STEINER |
Correspondent |
FISHER DIAGNOSTICS |
8365 VALLEY PIKE |
MIDDLETOWN,
VA
22645 -0307
|
|
Correspondent Contact |
JERALD P STEINER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 10/15/2001 |
Decision Date | 02/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|