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510(k) K782049

BIOASSAY SYSTEM, MS-2 SERUM by Abbott Laboratories — Product Code DJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1979
Date Received
December 8, 1978
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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Other clearances for product code DJB

  • K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM (September 29, 1983)
  • K831210 — GENTAMICIN TEST PACK-ACA (May 25, 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)
  • K790584 — AMES TDA/GENTGMICIN (June 15, 1979)
  • K790829 — EMIT GENTAMICIN ASSAY (May 15, 1979)