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510(k) K924339

Device
OLYMPUS AMYLASE REAGENT
Applicant
OLYMPUS CORP.
510(k) number
K924339
Product code
CIW  
Decision
Substantially Equivalent (SESE)
Decision date
1992-10-19
Date received
1992-08-28
Regulation
862.1070
Classification name
Starch-dye Bound Polymer, Amylase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
4 Nevada Dr. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CIW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931559DMA AMYLASE PROCEDUREData Medical Associates, Inc.1993-10-28
K884382AMYLASE TEST (AMYL) ITEM NUMBER: 65653Em Diagnostic Systems, Inc.1989-01-11
K850639ENZYMATIC ALPHA-AMYLASE REAGENT KITBio-Analytics Laboratories, Inc.1985-03-05
K812027KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)Eastman Kodak Company1981-08-03
K810584PHADEBAS ISOAMYLASE TESTPharmacia, Inc.1981-05-13
K810669PANTRAK E.K.Calbiochem-Behring Corp.1981-03-31
K782032UNITEST AMYLASEBoehringer Mannheim Corp.1979-03-02

Legacy Summary#

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FDA Review#

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