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510(k) K844231

SCEPTOR BETA-LACTAM PLUS MIC PANEL by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LTW

K844231 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "SCEPTOR BETA-LACTAM PLUS MIC PANEL". The FDA issued a decision of Substantially Equivalent on November 7, 1984. The device falls under product code LTW (Susceptibility Test Cards, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1984
Date Received
October 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Cards, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code LTW

  • K852613 — MIC-CONCEPT SYSTEM (September 20, 1985)
  • K853273 — PRECEPT CEFTRIAXONE (September 16, 1985)
  • K853772 — PRECEPT METHICILLIN (September 16, 1985)
  • K853685 — PRECEPT TM CARBENICILLIN (September 16, 1985)
  • K853596 — PRECEPT CEFOPERAZONE (September 16, 1985)
  • K853684 — PRECEPT KANAMYCIN (September 13, 1985)
  • K853688 — PRECEPT TM TOBRAMYCIN (September 13, 1985)
  • K853689 — PRECEPT TM MOXALACTAM (September 13, 1985)
  • K853687 — PRECEPT NETILMICIN 32-13 (September 13, 1985)
  • K853686 — PRECEPT TM AMIKACIN (September 13, 1985)

FDA data resources