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510(k) K780355

Device
Atroxin
Applicant
SIGMA CHEMICAL CO.
510(k) number
K780355
Product code
JCO
Decision
Substantially Equivalent (SESE)
Decision date
1978-04-18
Date received
1978-03-03
Regulation
864.8100
Classification name
Bothrops Atrox Reagent
Medical specialty
Hematology
Review panel
Hematology
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 JCO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955115VENOM TIEM REAGENTMedical Diagnostic Technologies, Inc.1996-04-03
K932787BATROXOBIN REAGENTBehring Diagnostics, Inc.1993-11-29
K896033FDP COLLECTION TUBESMedical Diagnostic Technologies, Inc.1989-10-27
K852519DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBEE.I. Dupont DE Nemours & Co., Inc.1985-08-12
K843207REPTILASE -PCBio/Data Corp.1984-10-23
K840210REPTILASE-R HA35Wellcome Diagnostics1984-04-23