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510(k) K864646

SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code GKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1987
Date Received
November 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hematocrit, Automated
Device Class
Class II
Regulation Number
864.5600
Review Panel
HE
Submission Type

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  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

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  • K880373 — IONOMETER E-HK AND ACCESSORIES (March 17, 1988)