Device Classification Name |
dye-indicator, ph (urinary, non-quantitative)
|
510(k) Number |
K830091 |
Device Name |
LITH A TEST TM |
Applicant |
LENAL CREATIVE APPROACHES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
LENAL CREATIVE APPROACHES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1550
|
Classification Product Code |
|
Date Received | 01/11/1983 |
Decision Date | 02/15/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|