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510(k) K822121

Device
ACRO PACK
Applicant
GELMAN SCIENCES, INC.
510(k) number
K822121
Product code
JRL  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-05
Date received
1982-07-19
Regulation
862.2050
Classification name
Unit, Filter, Membrane
Medical specialty
Clinical Chemistry
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 JRL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K820455CENTRIFREE MICROPARTITION SYSTEMAmicon, Inc.1982-03-15
K820224EMIT FREELEVEL SYSTEM ISyva Co.1982-02-23
K812750IL 703, STAT SEPARATORInstrumentation Laboratory CO1982-01-26
K813159VACUSHIELD TMGelman Sciences, Inc.1981-12-08
K810829ACRODISCGelman Sciences, Inc.1981-04-08
K801500ULTRAFREE CALCIUM FILTERMillipore Corp.1980-08-20
K790445ULTRA-FREEMillipore Corp.1979-06-28
K781043CEA-IMMERSIBLE SEPARATORMillipore Corp.1978-09-15

Legacy Summary#

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FDA Review#

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