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FDA 510(k)

MODIFIED IMIPENEM SUSCEPTIBILITY POWDER

K-Number: K880574 · 1988-05-04

ApplicantMerck, Sharp & Dohme
Decision Date1988-05-04
Product CodeJTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED IMIPENEM SUSCEPTIBILITY POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Merck, Sharp & Dohme. It received FDA 510(k) clearance on 1988-05-04 under 510(k) number K880574. 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 MODIFIED IMIPENEM SUSCEPTIBILITY POWDER?

MODIFIED IMIPENEM SUSCEPTIBILITY POWDER is a medical device that received FDA 510(k) clearance on 1988-05-04. The listed applicant is Merck, Sharp & Dohme. The 510(k) number is K880574.

When did MODIFIED IMIPENEM SUSCEPTIBILITY POWDER receive FDA 510(k) clearance?

MODIFIED IMIPENEM SUSCEPTIBILITY POWDER received FDA 510(k) clearance on 1988-05-04, under 510(k) number K880574.

Who is the listed applicant for MODIFIED IMIPENEM SUSCEPTIBILITY POWDER?

The FDA 510(k) record lists Merck, Sharp & Dohme as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED IMIPENEM SUSCEPTIBILITY POWDER?

The FDA product code for MODIFIED IMIPENEM SUSCEPTIBILITY POWDER is JTT.

Related Clinical Trials

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.

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Other records listing Merck, Sharp & Dohme as applicant

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.

K864442NORFLOXACIN SUSCEPTIBILITY POWDERK855071IMIPENEM SUSCEPTIBILITY POWDERK760605LIGHTCAST II CARBIDE BLADE

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 PreanalyticK872081CIPRO (TM) DIAGNOSTIC POWDERMiles PharmaceuticalsK864442NORFLOXACIN SUSCEPTIBILITY POWDERMerck, Sharp & DohmeK860031GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISKOrganon Teknika Corp.

Official Source

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

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