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510(k) K882101

Device
HEMOGLOBIN SCREENING DEVICE
Applicant
PORTABLE MEDICAL LABORATORIES, INC.
510(k) number
K882101
Product code
KSL  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-01
Date received
1988-05-11
Regulation
864.9320
Classification name
Solution, Copper Sulfate For Specific Gravity Determinations
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WARREN R SANBORN
Address
P.O. Box 667 Solana Beach CA US 92075 92075

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K803095COPPER SULFATE SOLUTION SP. GR.1.055Accra Laboratories, Inc.1981-03-06

Legacy Summary#

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FDA Review#

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