BITEK(TM) BLOOD CULTURE SYSTEM— 510(k) K875273

Name: FDA 510(k) clearance K875273
Creator: U.S. Food and Drug Administration
Published: 1988-01-22

Substantially Equivalent

Definitive Diagnostics, Inc.

FDA 510(k) clearance K875273 for BITEK(TM) BLOOD CULTURE SYSTEM, Substantially Equivalent on 1988-01-22. Applicant: Definitive Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Definitive Diagnostics, Inc.
Product code: Code JSG
Device class: Class 1
Regulation: 21 CFR 866.2300
Advisory panel: Microbiology
Date received: 1987-12-24
Decision date: 1988-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tualatin, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSG

view all

K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T30071988-07-01
K881522 — DEXTROSE AGAR1988-04-18
K881523 — DEXTROSE TRYPTONE BROTH1988-04-18
K881525 — COOKED MEAT MEDIUM1988-04-18
K881528 — CASEIN PEPTONE, LOW VITAMIN1988-04-18

More clearances from Definitive Diagnostics, Inc.

view all

K875259 — BITEK(TM) BLOOD CULTURE SYSTEM1988-01-27

Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

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.