Device Classification Name |
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
|
510(k) Number |
K905084 |
Device Name |
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV |
Applicant |
REAGENTS APPLICATIONS, INC. |
8225 MERCURY CT. |
SAN DIEGO,
CA
92111 -1203
|
|
Applicant Contact |
ALFRED E PEACOCK,JR |
Correspondent |
REAGENTS APPLICATIONS, INC. |
8225 MERCURY CT. |
SAN DIEGO,
CA
92111 -1203
|
|
Correspondent Contact |
ALFRED E PEACOCK,JR |
Regulation Number | 862.1215 |
Classification Product Code |
|
Date Received | 11/14/1990 |
Decision Date | 12/20/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|