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510(k) K992432

BACT/ALERT FN by Organon Teknika Corp. — Product Code MDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1999
Date Received
July 21, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Culturing
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

Other clearances by Organon Teknika Corp.

  • K003104 — BACT/ALERT CSR (October 20, 2000)
  • K000492 — MDA D-DIMER (June 7, 2000)
  • K000378 — BACT/ALERT MB CULTURE BOTTLE (March 2, 2000)
  • K994343 — BACT/ALERT SV (February 10, 2000)
  • K993423 — BACT/ALERT SA (December 15, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (December 14, 1999)
  • K993421 — BACT/ALERT SN (December 14, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992400 — BACTALERT FA (September 3, 1999)
  • K992401 — BACT/ALERT PF (September 3, 1999)

Other clearances for product code MDB

  • K222559 — BD BACTEC™ Myco/F Lytic Culture Vials (March 24, 2023)
  • K222591 — BD BACTEC™ Plus Aerobic/F Culture Vials (March 24, 2023)
  • K190405 — BACT/ALERT MP Reagent System (May 15, 2019)
  • K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus (February 11, 2019)
  • K173873 — BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a (March 16, 2018)
  • K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (March 28, 2017)
  • K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a P (February 9, 2017)
  • K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Pl (August 8, 2016)
  • K151866 — BD BACTEC Peds Plus/F Culture Vials (plastic) (February 25, 2016)
  • K141810 — BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (December 10, 2014)