Device Classification Name |
enzyme immunoassay, barbiturate
|
510(k) Number |
K944075 |
Device Name |
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST |
Applicant |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Applicant Contact |
SHERI HALL |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Correspondent Contact |
SHERI HALL |
Regulation Number | 862.3150
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/05/1994 |
Decision Date | 12/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|