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510(k) K910517

CAP SYSTEM RAST ASM/RIA AND ASM/FEIA by Pharmacia, Inc. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1991
Date Received
February 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

Other clearances by Pharmacia, Inc.

  • K974350 — ALLERGAN IMMUNO CAP M4, M8, K70 (February 9, 1998)
  • K972364 — UNICAP PHADIATOP (September 4, 1997)
  • K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (July 3, 1997)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (April 23, 1997)
  • K962274 — UNICAP 100 (September 12, 1996)
  • K941993 — PHARMACIA CAP SYSTEM PHADIATOP FEIA (January 30, 1996)
  • K954337 — GENOTROPIN MIXER (November 13, 1995)
  • K951025 — PISTON SYRINGE (October 19, 1995)
  • K952025 — ROBOCAP (July 26, 1995)

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