Device Classification Name |
helicobacter pylori
|
510(k) Number |
K000463 |
Device Name |
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG |
Applicant |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Applicant Contact |
EDWARD M LEVINE |
Correspondent |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Correspondent Contact |
EDWARD M LEVINE |
Regulation Number | 866.3110
|
Classification Product Code |
|
Date Received | 02/11/2000 |
Decision Date | 06/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|