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510(k) K974580

ALLERGEN IMMUNOCAP F256,F245,F207,F202 by Pharmacia & Upjohn Co. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1998
Date Received
December 8, 1997
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

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  • K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396 (January 5, 2000)
  • K993388 — ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F (December 1, 1999)
  • K993589 — VARELISA RNP ANTIBODIES (November 26, 1999)
  • K993109 — VARELISA RECOMBI ANA PROFILE (November 12, 1999)
  • K993108 — VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 (November 12, 1999)
  • K991945 — PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 (July 28, 1999)

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