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510(k) K831210

GENTAMICIN TEST PACK-ACA by E.I. Dupont DE Nemours & Co., Inc. — Product Code DJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1983
Date Received
April 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (March 30, 1995)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

Other clearances for product code DJB

  • K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM (September 29, 1983)
  • K821669 — AMES TDA GENTAMICIN TEST (December 15, 1982)
  • K812394 — MRI GENTAMICIN RIA KIT (September 8, 1981)
  • K811844 — COAT-A-COUNT GENTAMICIN RIA KIT (July 10, 1981)
  • K800537 — GAMMA STICK GENTAMICIN RIA KIT (April 24, 1980)
  • K791770 — QUANTIMUNE GENTAMICIN RIA GENTAMICIN (October 17, 1979)
  • K791547 — FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (October 12, 1979)
  • K782049 — BIOASSAY SYSTEM, MS-2 SERUM (August 28, 1979)
  • K790584 — AMES TDA/GENTGMICIN (June 15, 1979)
  • K790829 — EMIT GENTAMICIN ASSAY (May 15, 1979)