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FDA 510(k)

GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK

K-Number: K860031 · 1986-03-06

ApplicantOrganon Teknika Corp.
Decision Date1986-03-06
Product CodeJTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K860031. The device is classified under product code JTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK?

GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Organon Teknika Corp.. The 510(k) number is K860031.

When did GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK receive FDA 510(k) clearance?

GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK received FDA 510(k) clearance on 1986-03-06, under 510(k) number K860031.

Who is the listed applicant for GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK?

The FDA product code for GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK is JTT.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: JTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983310SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACINAccumed Intl., Inc.K935805PASCO MIC AND MIC/ID PANELSPasco Laboratories, Inc.K895362BACTEC PYRAZINAMIDE SUSCEPTIBILITY TESTBd Becton Dickinson Vacutainer Systems PreanalyticK880574MODIFIED IMIPENEM SUSCEPTIBILITY POWDERMerck, Sharp & DohmeK872081CIPRO (TM) DIAGNOSTIC POWDERMiles PharmaceuticalsK864442NORFLOXACIN SUSCEPTIBILITY POWDERMerck, Sharp & Dohme

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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