BACT/ALERT 3D MICROBIAL DETECTION SYSTEM— 510(k) K981736

Name: FDA 510(k) clearance K981736
Creator: U.S. Food and Drug Administration
Published: 1998-07-24

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K981736 for BACT/ALERT 3D MICROBIAL DETECTION SYSTEM, Substantially Equivalent on 1998-07-24. Applicant: Organon Teknika Corp.. Device class: 1.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code MDB
Device class: Class 1
Regulation: 21 CFR 866.2560
Advisory panel: Microbiology
Date received: 1998-05-18
Decision date: 1998-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MDB

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K260213 — BD BACTEC FXI Culture System2026-05-28
K222559 — BD BACTEC Myco/F Lytic Culture Vials2023-03-24
K222591 — BD BACTEC Plus Aerobic/F Culture Vials2023-03-24
K190405 — BACT/ALERT MP Reagent System2019-05-15
K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus2019-02-11

More clearances from Organon Teknika Corp.

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K003104 — BACT/ALERT CSR2000-10-20
K000492 — MDA D-DIMER2000-06-07
K000378 — BACT/ALERT MB CULTURE BOTTLE2000-03-02
K994343 — BACT/ALERT SV2000-02-10
K993423 — BACT/ALERT SA1999-12-15

Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.