Device Classification Name |
urinalysis controls (assayed and unassayed)
|
510(k) Number |
K874890 |
Device Name |
QUANTIMETRIX URINE DIPSTICK CONTROL |
Applicant |
QUANTIMETRIX MEDICAL INDUSTRIES |
11953 SOUTH PRAIRIE AVE. |
HAWTHORNE,
CA
90250
|
|
Applicant Contact |
ERNEST S JOHNSON |
Correspondent |
QUANTIMETRIX MEDICAL INDUSTRIES |
11953 SOUTH PRAIRIE AVE. |
HAWTHORNE,
CA
90250
|
|
Correspondent Contact |
ERNEST S JOHNSON |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 12/01/1987 |
Decision Date | 01/21/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|