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510(k) K853546

Device
Abbott Cation Supplement Solution
Applicant
ABBOTT LABORATORIES
510(k) number
K853546
Product code
JSK
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-06
Date received
1985-08-26
Regulation
866.2450
Classification name
Supplement, Culture Media
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BEVERLY CHAMBERS
Address
1921 Hurd Dr. P.O.Box 152020 Irving TX US 75015 75015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881949ATS NAC-PAC SETAlpha-Tec Systems, Inc.1988-05-25
K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42Alpha-Tec Systems, Inc.1988-05-13
K881566HEMOGLOBIN POWDERAcumedia Manufacturers, Inc.1988-04-18
K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTUREHazleton Research Products, Inc.1986-06-10
K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)Flow Laboratories, Inc.1986-05-20
K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)Flow Laboratories, Inc.1986-05-20
K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEFlow Laboratories, Inc.1986-05-20
K855172KWI (TM) G-CO/TWOMicro-Bio-Logics1986-02-20
K850302SUPLEX & SUPLEX DILUENTPro-Lab, Inc.1985-03-22
K850301YEAST DIALYSATEPro-Lab, Inc.1985-03-20
K850299C.N.V.T.Pro-Lab, Inc.1985-03-20
K850300MUCOLYSEPro-Lab, Inc.1985-03-20
K850307CAMPYLOBACTER SUPPLEMENT-BLASER/WANGPro-Lab, Inc.1985-03-20
K850308C.L.A.T.Pro-Lab, Inc.1985-03-20
K850738SUPPLEMENT FOR CULTURE MEDIUMRoseville Medical Laboratoriesu1985-03-20