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510(k) K811791

Device
PHOSPHATE BUFFERED SALINE (1X)
Applicant
DUTCHLAND LABORATORIES, INC.
510(k) number
K811791
Product code
JCC  
Decision
Substantially Equivalent (SESE)
Decision date
1981-08-25
Date received
1981-06-24
Regulation
864.4010
Classification name
Ph Buffer
Medical specialty
Pathology
Review panel
Clinical Chemistry
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

Other 510(k) Records For Product Code JCC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842918SCOTTS TAP WATER SUBSTITUTEE K Ind., Inc.1984-09-11
K842914WRIGHT STAIN BUFFERE K Ind., Inc.1984-09-07
K841423SCOTTS TAP WATER SUBSTITUTE 7Reagent Laboratory, Inc.1984-05-22
K811251CITRATE BUFFERBioscientific1981-05-21
K792574MOPSO BUFFERElectrophoresis Corp. of America1980-01-21
K770508SMAC SYSTEMMid Tech, Inc.1977-05-09

Legacy Summary#

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FDA Review#

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