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510(k) K942241

DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN by Dupont Medical Products — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1994
Date Received
May 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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  • K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (March 9, 1995)
  • K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGE (December 28, 1994)
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  • K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (October 20, 1994)
  • K941146 — DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (October 3, 1994)
  • K942640 — DUPONT DIMENSION AMYLASE METHOD (September 9, 1994)

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