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510(k) K875275

Device
WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
Applicant
STERLING DRUG, INC.
510(k) number
K875275
Product code
JTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-01-27
Date received
1987-12-24
Regulation
866.2540
Classification name
Bath, Incubators/water, All
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CARL E CALCAGNI
Address
90 Park Ave. New York NY US 10016 10016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K853379PLATE INCUBATORScientific Sales Intl., Inc.1985-09-03
K831592ANHYDRIC INCUBATORS, CULTURE INCUBATORBoekel Industries, Inc.1983-06-16
K830322C.A.T. REAGENT KITRemel Co.1983-03-28
K830227AUTOMATED ELISA READER LBI 300Bionetic Laboratory Products1983-03-10
K830405LBI-100 37DEGREES INCUBATORBionetic Laboratory Products1983-03-10
K822564WATER BATHBoekel Industries, Inc.1982-09-14
K812826FORMA CH/P GAS PROCESSORForma Scientific, Inc.1981-10-23
K812340TITERTEK MICROPLATE INCUBATORFlow Laboratories, Inc.1981-09-23
K801462SPOR-O-THERMMdt Corp., Inc.1980-07-28
K792060TEMPTRONIC 100 WATER BATHSybron Corp.1979-12-04
K760928BLOOD BANK DRI-BATHThermolyne Corp.1977-01-10

Legacy Summary#

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FDA Review#

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