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510(k) K803054

Device
SAF FIXATIVE
Applicant
REMEL CO.
510(k) number
K803054
Product code
IGB  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-22
Date received
1980-12-02
Regulation
864.4010
Classification name
Solution, Formalin-sodium Acetate
Medical specialty
Pathology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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