FDA.reportPublic FDA data

510(k) K811777

Device
Helena Plasminogen Quiplate Procedure
Applicant
HELENA LABORATORIES
510(k) number
K811777
Product code
DDX
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-02
Date received
1981-06-23
Regulation
866.5715
Classification name
Plasminogen, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
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 DDX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941346PLASMINOGEN RID TEST KITThe Binding Site, Ltd.1994-09-09
K884766BERICHROM(R) PLASMINOGENBehring Diagnostics, Inc.1989-01-04
K864212IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory CO1986-12-04
K854572COATEST PLASMINOGENKabivitrum, Inc.1986-02-26
K850410GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAYWarner-Lambert Co.1985-05-08
K832591DIACROM *PLGWellcome Diagnostics1983-11-21
K812625ACA PLASMINOGEN TEST PACKE.I. Dupont DE Nemours & Co., Inc.1981-09-29
K781478PLASMINOGEN ASSAYDade, Baxter Travenol Diagnostics, Inc.1978-11-15
K772085LAS-R HUMAN PLASMINOGEN TESTHyland Therapeutic Div., Travenol Laboratories1978-01-24