SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH— 510(k) K851250

Name: FDA 510(k) clearance K851250
Creator: U.S. Food and Drug Administration
Published: 1985-04-22

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K851250 for SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH, Substantially Equivalent on 1985-04-22. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JSG
Device class: Class 1
Regulation: 21 CFR 866.2300
Advisory panel: Microbiology
Date received: 1985-03-27
Decision date: 1985-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSG

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

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K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS1998-12-15
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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.