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510(k) K832345

POLYSTYRENE MICROTITER WELL IMMUNOSOR by Diagnostic Reagent Tech. — Product Code DGC

K832345 is an FDA 510(k) premarket notification submitted by Diagnostic Reagent Tech. for the device "POLYSTYRENE MICROTITER WELL IMMUNOSOR". The FDA issued a decision of Substantially Equivalent on November 25, 1983. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Diagnostic Reagent Tech. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1983
Date Received
July 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Diagnostic Reagent Tech.

  • K843302 — NEW ALLERG. COATED MICROFILTER WELL STRI (October 4, 1984)
  • 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 DGC

  • K231151 — Kenota 1 Total IgE; Kenota 1 (instrument) (May 31, 2024)
  • K214068 — Quantia IgE (February 21, 2023)
  • K220178 — Total Immunoglobulin E (IgE) (March 23, 2022)
  • K193493 — ADVIA Centaur Total IgE (tIgE) (January 15, 2020)
  • K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP To (July 28, 2016)
  • K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL L (February 24, 2014)
  • K063425 — DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONT (February 15, 2007)
  • K050493 — QUANTIA IGE (August 16, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K034057 — LACRYTEST (March 9, 2004)

FDA data resources