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510(k) K800409

ADT BONE MARROW BIOPSY ASPIRATION TRAY by A.D.T. Lab Industries — Product Code GAA

K800409 is an FDA 510(k) premarket notification submitted by A.D.T. Lab Industries for the device "ADT BONE MARROW BIOPSY ASPIRATION TRAY". The FDA issued a decision of Substantially Equivalent on April 28, 1980. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. A.D.T. Lab Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1980
Date Received
February 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by A.D.T. Lab Industries

  • K812297 — A.D.T. PROCEDURES TRAY (September 28, 1981)
  • K801754 — ADT BONE MARROW ASPIRATION NEEDLE (August 20, 1980)
  • K801753 — ADT BONE MARROW BIOPSY-ASPIR. NEELDE (August 20, 1980)
  • K800412 — ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW (April 28, 1980)
  • K800410 — ADT BONE MARROW BIOPSY-ASPIRATION TRAY (April 28, 1980)
  • K800417 — ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL (April 28, 1980)
  • K800418 — ADT DISPOSABLE THIN NEEDLE ASPIRATION (April 28, 1980)
  • K800414 — ADT SOFT TISSUE BIOPSY TRAY (April 28, 1980)
  • K800411 — ASPIRATION TRAY W/FERRIS DISP. ILLINOIS (April 28, 1980)
  • K800408 — ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE (April 28, 1980)

Other clearances for product code GAA

  • K223625 — CapnoSpot™ Pneumothorax Decompression Indicator (March 28, 2023)
  • K102274 — ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (June 15, 2011)
  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K974741 — MANAN ACCURA NEEDLE (January 8, 1998)
  • K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (September 11, 1996)
  • K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW (July 19, 1996)
  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
  • K940024 — MANAN GENERAL PURPOSE INTRODUCER NEEDLE (February 25, 1994)

FDA data resources