Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K861420 |
Device Name |
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL |
Applicant |
QUANTIMETRIX CORP. |
4955 WEST 145 ST. |
HAWTHORNE,
CA
90250 -6703
|
|
Applicant Contact |
JOHNSON, III |
Correspondent |
QUANTIMETRIX CORP. |
4955 WEST 145 ST. |
HAWTHORNE,
CA
90250 -6703
|
|
Correspondent Contact |
JOHNSON, III |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 04/15/1986 |
Decision Date | 09/16/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|