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510(k) K000132

ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 by Pharmacia & Upjohn Co. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2000
Date Received
January 18, 2000
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 & Upjohn Co.

  • K003414 — VARELISA TG (THYROGLOBULIN) ANTIBODIES, (November 27, 2000)
  • K002556 — CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 (October 31, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)
  • 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)
  • K991048 — ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214 (May 14, 1999)

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