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510(k) K831253

Device
Lancer Hemoglobin Analyzer Reagents
Applicant
SHERWOOD MEDICAL CO.
510(k) number
K831253
Product code
KMG
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-09
Date received
1983-04-18
Regulation
880.6710
Classification name
Purifier, Water, Ultraviolet, Medical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
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 KMG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012029REMEDY MODEL 2Z12Apollo Corp.2001-12-31
K832288HEMOGLOBINOMETERMallinckrodt Critical Care1983-09-01
K813045AQUANOMICS, #SP36SFCooper-Hewitt Electric Co.1981-12-02
K813046AQUANOMICS, #HHU60Cooper-Hewitt Electric Co.1981-12-02
K813047AQUANOMICS, MINI 60LCooper-Hewitt Electric Co.1981-12-02
K813048AQUANOMICS, #MP2SFCooper-Hewitt Electric Co.1981-12-02
K813049AQUANOMICS, #HHU100Cooper-Hewitt Electric Co.1981-12-02
K813050AQUANOMICS, #MP4SFCooper-Hewitt Electric Co.1981-12-02