Device Classification Name |
enzyme immunoassay, carbamazepine
|
510(k) Number |
K963673 |
Device Name |
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS |
Applicant |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Applicant Contact |
ANNETTE HELLIE |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Correspondent Contact |
ANNETTE HELLIE |
Regulation Number | 862.3645
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/13/1996 |
Decision Date | 02/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|