Home / 510(k) Clearances / K760881

510(k) K760881

FEBRILE ANTIGEN CONTROL SERA by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1976
Date Received
October 21, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Febrile (Weil-Felix), All Groups
Device Class
Class I
Regulation Number
866.3410
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 GSZ

  • K885110 — PROTEUS OX-19 IFA* (August 15, 1989)
  • K760097 — FEBRILE ANTIGENS & CONTROL SERUMS (August 3, 1976)