Home / 510(k) Clearances / K991048

510(k) K991048

ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 by Pharmacia & Upjohn Co. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1999
Date Received
March 30, 1999
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.

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  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)
  • K000132 — ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16 (February 18, 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)
  • K993108 — VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 (November 12, 1999)
  • K993109 — VARELISA RECOMBI ANA PROFILE (November 12, 1999)
  • K991945 — PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 (July 28, 1999)

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