Device Classification Name |
Chromatographic Separation, Cpk Isoenzymes
|
510(k) Number |
K831391 |
Device Name |
SHOT GUN KIT FOR CK-MB |
Applicant |
SERAPINE CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SERAPINE CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 04/29/1983 |
Decision Date | 11/04/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|