REGAN-LOWE AGAR— 510(k) K861734

Name: FDA 510(k) clearance K861734
Creator: U.S. Food and Drug Administration
Published: 1986-05-16

Substantially Equivalent

Gibco Laboratories Life Technologies, Inc.

FDA 510(k) clearance K861734 for REGAN-LOWE AGAR, Substantially Equivalent on 1986-05-16. Applicant: Gibco Laboratories Life Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Gibco Laboratories Life Technologies, Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1986-05-06
Decision date: 1986-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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K881526 — CHAPMAN STONE MEDIUM1988-04-18
K881530 — BRILLIANT GREEN AGAR W/SULFADIAZINE1988-04-18
K881544 — LITTMAN AGAR1988-04-18

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K871855 — SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM1987-05-26
K871541 — MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C02261987-04-29
K870134 — MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE1987-02-04
K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM1987-01-05
K864014 — LOMBARD DOWELL AGAR BASE1986-10-29

Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.