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510(k) K851393

DUPONT PREP FOUR-SOLVENT RETROFIT KIT by E.I. Dupont DE Nemours & Co., Inc. — Product Code JJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1985
Date Received
April 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clinical Sample Concentrator
Device Class
Class I
Regulation Number
862.2310
Review Panel
CH
Submission Type

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  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • 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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  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K935496 — NANOSEP N10 (April 26, 1994)
  • K930168 — CENTRICON -50 CONCENTRATOR (August 5, 1993)
  • K893733 — CENTRICON CONCENTRATOR (July 20, 1989)
  • K871290 — CENTRICELL(TM) (August 5, 1987)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)