Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K992900 |
Device Name |
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
PRICILLA A HAMILL |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
PRICILLA A HAMILL |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 08/30/1999 |
Decision Date | 11/24/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|