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510(k) K800693

Device
STANBIO PROSTATIC ACID PHOSPHATASE TEST
Applicant
STANBIO LABORATORY
510(k) number
K800693
Product code
CKE  
Decision
Substantially Equivalent (SESE)
Decision date
1980-04-16
Date received
1980-03-27
Regulation
862.1020
Classification name
Acid Phosphatase, Thymolphthale Inmonophosphate
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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CKE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914167CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASEEastman Kodak Company1992-03-17
K915705ACID PHOSPHATASE REAGENT SETTech Intl. Co.1992-02-27
K873726ACID PHOSPHATASE TESTKing Diagnostics, Inc.1988-01-27
K864230DIMENSION (TM) CLINICAL CHEMISTRY SYSTEME.I. Dupont DE Nemours & Co., Inc.1986-11-28
K860476ACID PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.1986-03-05
K843380ACID PHOSPHATASE ASSAY KITDiagnostic Chemicals, Ltd. (Usa)1984-09-20
K821526ACID PHOSPHATASE REAGENT SETAnco Medical Reagents & Assoc.1982-06-10
K790524DATA-ZYME ACIA PHOSPHATASE PROCEDUREData Medical Associates, Inc.1979-05-23

Legacy Summary#

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FDA Review#

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