THIOGLYCOLLATE MED. W/O INDICATOR— 510(k) K800985

Name: FDA 510(k) clearance K800985
Creator: U.S. Food and Drug Administration
Published: 1980-05-23

Substantially Equivalent

Quality Assurance Laboratory, Inc.

FDA 510(k) clearance K800985 for THIOGLYCOLLATE MED. W/O INDICATOR, Substantially Equivalent on 1980-05-23. Applicant: Quality Assurance Laboratory, Inc.. Device class: 1.

Clearance details

Applicant: Quality Assurance Laboratory, Inc.
Product code: Code JSG
Device class: Class 1
Regulation: 21 CFR 866.2300
Advisory panel: Microbiology
Date received: 1980-04-23
Decision date: 1980-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K881528 — CASEIN PEPTONE, LOW VITAMIN1988-04-18

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K800978 — XYLOSE LYSINE DESOXYCHOLATE AGAR1980-05-28
K800981 — CHOCOLATE AGAR W/ENRICHMENTS1980-05-28
K800977 — THAYER-MARTIN AGAR1980-05-23

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.