Device Classification Name |
formaldehyde (formalin, formol)
|
510(k) Number |
K792705 |
Device Name |
PARA-PAK FORMALIN |
Applicant |
MERIDIAN DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MERIDIAN DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.4010
|
Classification Product Code |
|
Date Received | 12/27/1979 |
Decision Date | 01/21/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Pathology
|
510k Review Panel |
Pathology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|