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FDA 510(k)

IMIPENEM SUSCEPTIBILITY POWDER

K-Number: K855071 · 1986-03-06

ApplicantMerck, Sharp & Dohme
Decision Date1986-03-06
Product CodeJTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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 1986-03-06 under 510(k) number K855071. 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 IMIPENEM SUSCEPTIBILITY POWDER?

IMIPENEM SUSCEPTIBILITY POWDER is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Merck, Sharp & Dohme. The 510(k) number is K855071.

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

IMIPENEM SUSCEPTIBILITY POWDER received FDA 510(k) clearance on 1986-03-06, under 510(k) number K855071.

Who is the listed applicant for 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 IMIPENEM SUSCEPTIBILITY POWDER?

The FDA product code for 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K880574MODIFIED IMIPENEM SUSCEPTIBILITY POWDERK864442NORFLOXACIN 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 PreanalyticK880574MODIFIED IMIPENEM SUSCEPTIBILITY POWDERMerck, Sharp & DohmeK872081CIPRO (TM) DIAGNOSTIC POWDERMiles PharmaceuticalsK864442NORFLOXACIN SUSCEPTIBILITY POWDERMerck, Sharp & Dohme

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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