Device Classification Name |
electrode, ion specific, urea nitrogen
|
510(k) Number |
K925550 |
Device Name |
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 |
Applicant |
HICHEM DIAGNOSTICS |
231 N. PUENTE ST. |
BREA,
CA
92621
|
|
Applicant Contact |
WYNN STOCKING |
Correspondent |
HICHEM DIAGNOSTICS |
231 N. PUENTE ST. |
BREA,
CA
92621
|
|
Correspondent Contact |
WYNN STOCKING |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 11/03/1992 |
Decision Date | 04/20/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|