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510(k) K760161

Device
TEST, ACID PHOSPHATASE
Applicant
PRINCETON BIOMEDIX
510(k) number
K760161
Product code
CJR  
Decision
Substantially Equivalent (SESE)
Decision date
1976-07-20
Date received
1976-07-02
Regulation
862.1020
Classification name
Acid Phosphatase, Thymol Blue Monophosphate
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CJR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842516SANDARE ACID PHOSPHATASE PROCEDURESandare Chemical Co., Inc.1984-08-17

Legacy Summary#

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FDA Review#

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