Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K970862 |
Device Name |
SPINALSCOPICS |
Applicant |
QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. |
REDONDO BEACH,
CA
90278 -1205
|
|
Applicant Contact |
EVY JOHNSON |
Correspondent |
QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. |
REDONDO BEACH,
CA
90278 -1205
|
|
Correspondent Contact |
EVY JOHNSON |
Regulation Number | 862.1660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/07/1997 |
Decision Date | 04/08/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|