FDA.reportPublic FDA data

510(k) K812002

Device
Eluaid
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
510(k) number
K812002
Product code
GGK
Decision
Substantially Equivalent (SESE)
Decision date
1981-10-28
Date received
1981-07-14
Regulation
864.8540
Classification name
Products, Red-Cell Lysing Products
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
125 Mark Ave. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GGK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter Immunology1988-11-30
K883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.1988-10-12
K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLC1987-10-20
K873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott Diagnostics1987-09-09
K863114PIASTRINITJ. D. Assoc.1986-11-06
K863503HEMOLYSEReagent Laboratory, Inc.1986-10-03
K850944NSI LYSING-D REAGENT -4000 MLNobel Scientific Industries, Inc.1985-03-29
K850097LASER-LYSEHematology Marketing Assoc.1985-03-29
K842938ACETIC ACID 1% V/VE K Ind., Inc.1984-09-14
K842937ACETIC ACID 2% V/VE K Ind., Inc.1984-09-12
K842936ACETIC ACID, 3% V/VE K Ind., Inc.1984-09-12
K842935ACETIC ACID, 5% V/VE K Ind., Inc.1984-09-12
K842069IDL-LYSING REAGENTInterscience Diagnostics, Inc.1984-07-02
K841800LYSING & HEMOGLOBIN REAGENTReagent Laboratory, Inc.1984-05-31
K840289LYSE-TECMedilab Corp.1984-03-05