VACUTAINER BRAND AGAR SLANT— 510(k) K862761

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code KZI

Device class

Class 1

Regulation

21 CFR 866.2330

Advisory panel

Microbiology

Date received

1986-07-22

Decision date

1986-08-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Franklin Lakes, NJ, US

• K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1988-10-25
• K881995 — DIAMOND'S MEDIUM MODIFIED1988-06-02
• K880122 — MIDDLEBROOK 7H9 BROTH1988-03-31
• K880131 — LOWENSTEIN-JENSEN, GRUFT1988-03-31
• K880134 — MIDDLEBROOK 7H11 AGAR1988-03-31

• K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
• K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
• K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
• K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
• K001364 — BD DIRECTIGEN FLU A+B2000-06-28

Malfunction

2,834

Total

2,834

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 →