MONO-CUBE(TM)— 510(k) K890991

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K890991 for MONO-CUBE(TM), Substantially Equivalent on 1989-03-16. Applicant: Difco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1989-02-27
Decision date: 1989-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTN

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More clearances from Difco Laboratories, Inc.

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K963508 — DISPENS-O-DISC MEROPENEM1996-09-26
K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)1996-04-26
K954783 — DRYSLIDE CARTARRHALIS1996-02-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.