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510(k) K802608

Device
HEMATIC BLOOD MIXER
Applicant
HELMER LABS, INC.
510(k) number
K802608
Product code
KSQ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-11
Date received
1980-10-21
Regulation
864.9195
Classification name
Device, Blood Mixing And Blood Weighing
Medical specialty
Hematology
Review panel
Hematology
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 KSQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842746HYCEL ROTOR-MIXER AND/OR MULTIR&D Systems, Inc.1984-08-17
K820712SEPCOR UNIT COLLECTION MONITORSeparation Science Corp.1982-05-07
K812533PLATELET AGITATORHelmer Labs, Inc.1981-09-29
K810617MOBILE MATIC AUTOMATIC DONOR SCALELifeline Instruments, Inc.1981-04-07
K800104ROYCO MODEL 951 CELL MIXERRoyco Instruments1980-02-06
K780189PLATELET ROTATORTravenol Laboratories, S.A.1978-03-30
K760743DONORMATIC (BLOOD COLLECTION DEVICE)Lifeline Instruments, Inc.1976-12-06

Legacy Summary#

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FDA Review#

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