Device Classification Name |
dye-indicator, ph (urinary, non-quantitative)
|
510(k) Number |
K830824 |
Device Name |
URINE SCREENING KIT |
Applicant |
SYN-KIT, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SYN-KIT, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1550
|
Classification Product Code |
|
Date Received | 03/15/1983 |
Decision Date | 06/12/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|