Device Classification Name |
fluorometric method, cpk or isoenzymes
|
510(k) Number |
K022118 |
Device Name |
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) |
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 | 862.1215
|
Classification Product Code |
|
Date Received | 07/01/2002 |
Decision Date | 07/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|