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510(k) K850485

ROTOR SYSTEMS A/S-400 & LA/S-400 by E.I. Dupont DE Nemours & Co., Inc. — Product Code JQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
February 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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

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