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510(k) K992401

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

K992401 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "BACT/ALERT PF". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1999
Date Received
July 19, 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)
  • K992432 — BACT/ALERT FN (September 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992400 — BACTALERT FA (September 3, 1999)

Other clearances for product code MDB

  • K260213 — BD BACTEC FXI Culture System (May 28, 2026)
  • 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)

FDA data resources