Device Classification Name |
Calibrators, Ethyl Alcohol
|
510(k) Number |
K882117 |
Device Name |
ETHYL ALCOHOL STANDARD |
Applicant |
VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. |
PROVIDENCE,
RI
02907
|
|
Applicant Contact |
ANTHONY J DIMONTE |
Correspondent |
VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. |
PROVIDENCE,
RI
02907
|
|
Correspondent Contact |
ANTHONY J DIMONTE |
Regulation Number | 862.3200
|
Classification Product Code |
|
Date Received | 05/19/1988 |
Decision Date | 08/04/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|