Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K860942 |
Device Name |
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID |
Applicant |
QUANTIMETRIX CORP. |
4955 WEST 145 ST. |
HAWTHORNE,
CA
90250 -6703
|
|
Applicant Contact |
ERNEST S JOHNSON |
Correspondent |
QUANTIMETRIX CORP. |
4955 WEST 145 ST. |
HAWTHORNE,
CA
90250 -6703
|
|
Correspondent Contact |
ERNEST S JOHNSON |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 03/12/1986 |
Decision Date | 05/23/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|