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510(k) K810779

Device
EARLE'S BALANCED SALTS SOULTION
Applicant
DUTCHLAND LABORATORIES, INC.
510(k) number
K810779
Product code
KIP  
Decision
Substantially Equivalent (SESE)
Decision date
1981-05-13
Date received
1981-03-23
Regulation
864.2875
Classification name
Formulations, Balanced Salt Solutions
Medical specialty
Hematology
Review panel
Clinical Chemistry
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 KIP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870491KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002Sigma Chemical Co.1987-03-30
K870486EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509Sigma Chemical Co.1987-03-30
K870484HANKS' BALANCED SALTS (HBSS) NO. H1387Sigma Chemical Co.1987-03-30
K870482(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030Sigma Chemical Co.1987-03-30
K860784DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2Tissue Culture Innovations1986-03-12
K844878TRYPSIN 10X - 1:250 IN HBSS W/O CA & MGHazleton Research Products, Inc.1985-02-25
K844877HEPES BUFFER IM IN NORMAL SALINEHazleton Research Products, Inc.1985-02-25
K842724SALINE 0.85% W/O PRESERVATIVEE K Ind., Inc.1984-08-03
K842725SALINE, 0.85%W/PRESERVATIVEE K Ind., Inc.1984-08-03
K842723SALINE, 1.3% W/O PRESERVATIVEE K Ind., Inc.1984-08-03
K820928EBS POWDERDutchland Laboratories, Inc.1982-04-21
K820927HBS POWDERDutchland Laboratories, Inc.1982-04-21
K820923DULBECCO'S PBS POWDERDutchland Laboratories, Inc.1982-04-21
K810777HANKS' BALANCED SALTS SOLUTION (MODIF.)Dutchland Laboratories, Inc.1981-05-08
K810766HANKS' BALANCED SALT SOLUTION W/O CA-MGDutchland Laboratories, Inc.1981-05-08

Legacy Summary#

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FDA Review#

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