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510(k) K843302

NEW ALLERG. COATED MICROFILTER WELL STRI by Diagnostic Reagent Tech. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1984
Date Received
August 23, 1984
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 Diagnostic Reagent Tech.

  • K832345 — POLYSTYRENE MICROTITER WELL IMMUNOSOR (November 25, 1983)
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  • K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (November 21, 1983)
  • K831496 — ALLERGEN IMMUNOSORBENTS IP SPECIFIC E (August 8, 1983)
  • K831774 — LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- (July 18, 1983)
  • K830005 — IP SPECIFIC G (June 2, 1983)
  • K830653 — POLYSTYRENE MICROTITER PLATE IMMUNOSORB (April 8, 1983)
  • K830495 — POLYSTYRENE MICROTITER PLATE IMMUNOSOR (April 5, 1983)
  • K821094 — IP SPECIFIC E (May 7, 1982)

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