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510(k) K830005

IP SPECIFIC G by Diagnostic Reagent Tech. — Product Code DAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1983
Date Received
January 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
PA
Submission Type

Other clearances by Diagnostic Reagent Tech.

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

  • K832675 — ANA MICROZYME TEST SYS #1610 (September 12, 1983)
  • K831927 — ANTINUCLEAR ANTIBODY TEST KIT (July 18, 1983)
  • K822911 — ANAZYME ANA PEROXIDASE TEST SYSTEM (October 22, 1982)
  • K791749 — INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL (October 17, 1979)