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510(k) K813404

Device
FREEZE DRIED FICIN
Applicant
BIOLOGICAL CORP. OF AMERICA
510(k) number
K813404
Product code
KSK  
Decision
Substantially Equivalent (SESE)
Decision date
1982-02-10
Date received
1981-12-07
Regulation
864.9400
Classification name
Solution, Stabilized Enzyme
Medical specialty
Hematology
Review panel
Immunology
Device class
2
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 KSK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONGamma Biologicals, Inc.1982-03-04
K810803FREEZE DRIED PAPAINBiological Corp. of America1981-07-21
K780962AUTOMATED ENZYMEHyland Therapeutic Div., Travenol Laboratories1978-07-27
K760123AUTOZYMEBd Becton Dickinson Vacutainer Systems Preanalytic1976-07-20

Legacy Summary#

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FDA Review#

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