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510(k) K831496

ALLERGEN IMMUNOSORBENTS IP SPECIFIC E by Diagnostic Reagent Tech.

K831496 is an FDA 510(k) premarket notification submitted by Diagnostic Reagent Tech. for the device "ALLERGEN IMMUNOSORBENTS IP SPECIFIC E". The FDA issued a decision of Substantially Equivalent on August 8, 1983. Diagnostic Reagent Tech. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1983
Date Received
May 10, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Diagnostic Reagent Tech.

  • K843302 — NEW ALLERG. COATED MICROFILTER WELL STRI (October 4, 1984)
  • K832345 — POLYSTYRENE MICROTITER WELL IMMUNOSOR (November 25, 1983)
  • K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (November 21, 1983)
  • K832344 — POLYSTYRENE MICROTITER PLATE IMMUNO- (November 21, 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)

FDA data resources