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510(k) K800537

GAMMA STICK GENTAMICIN RIA KIT by Alpha Gamma Laboratory — Product Code DJB

K800537 is an FDA 510(k) premarket notification submitted by Alpha Gamma Laboratory for the device "GAMMA STICK GENTAMICIN RIA KIT". The FDA issued a decision of Substantially Equivalent on April 24, 1980. The device falls under product code DJB (Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3450. Alpha Gamma Laboratory has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1980
Date Received
March 10, 1980
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

Other clearances by Alpha Gamma Laboratory

  • K810011 — GAMMA STICK 125-1 TOBRAMYCIN RIA KIT (January 28, 1981)
  • K800538 — GAMMA STICK CORTISOL RIA KIT/STICK KIT (April 24, 1980)
  • K780492 — GAMMA STIK 125I T3 UPTAKE KIT (April 28, 1978)

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)
  • 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)

FDA data resources