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510(k) K875066

ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT by Dexall Biomedical Labs, Inc. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
December 9, 1987
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 Dexall Biomedical Labs, Inc.

  • K885269 — ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS (February 7, 1989)
  • K864696 — ALLERG*ENS ENZYME IMMUNOASSAY KIT (March 17, 1987)
  • K853607 — ALLERG-E IGE ENZYME IMMUNOASSAY KIT (November 7, 1985)

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