Device Classification Name |
visual, pregnancy hcg, prescription use
|
510(k) Number |
K980173 |
Device Name |
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 |
Applicant |
BECKMAN INSTRUMENTS, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
SANDRA F SCHWARTZ |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
SANDRA F SCHWARTZ |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 01/20/1998 |
Decision Date | 03/18/1998 |
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
|
|
|