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510(k) K934843

URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
October 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (March 30, 1995)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

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