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510(k) K843302

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

K843302 is an FDA 510(k) premarket notification submitted by Diagnostic Reagent Tech. for the device "NEW ALLERG. COATED MICROFILTER WELL STRI". The FDA issued a decision of Substantially Equivalent on October 4, 1984. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Diagnostic Reagent Tech. has at least 9 other 510(k) clearances on record.

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)
  • K832344 — POLYSTYRENE MICROTITER PLATE IMMUNO- (November 21, 1983)
  • 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)

Other clearances for product code DHB

  • K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Aller (September 4, 2026)
  • K261027 — NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture (July 24, 2026)
  • K260591 — NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);C (July 21, 2026)
  • K260280 — NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Cap (June 18, 2026)
  • K260059 — NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excel (May 15, 2026)
  • K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Cap (January 16, 2026)
  • K252493 — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture (December 23, 2025)
  • K242531 — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum h (April 23, 2025)
  • K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle (August 3, 2022)
  • K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, (February 18, 2022)

FDA data resources