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510(k) K914040

Device
PHOSPHOLIPID REAGENT SET
Applicant
STERLING DIAGNOSTICS, INC.
510(k) number
K914040
Product code
JNT  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-30
Date received
1991-09-10
Regulation
862.1575
Classification name
Chromatographic, Phospholipids
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID L CALLENDER
Address
6226 Product Dr. Sterling Heights MI US 48312 48312

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JNT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K922792ZITHROMAXDifco Laboratories, Inc.1992-07-30
K792349SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.Pfizer, Inc.1980-03-12

Legacy Summary#

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FDA Review#

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