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FDA 510(k)

REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK

K-Number: K964421 · 1996-12-06

ApplicantRemel, L.P.
Decision Date1996-12-06
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel, L.P.. It received FDA 510(k) clearance on 1996-12-06 under 510(k) number K964421. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK?

REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK is a medical device that received FDA 510(k) clearance on 1996-12-06. The listed applicant is Remel, L.P.. The 510(k) number is K964421.

When did REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK receive FDA 510(k) clearance?

REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK received FDA 510(k) clearance on 1996-12-06, under 510(k) number K964421.

Who is the listed applicant for REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK?

The FDA 510(k) record lists Remel, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK?

The FDA product code for REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK is JTN.

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Other records listing Remel, L.P. 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.

K972359REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCINK964315REMEL STAPH LATEX KITK96104610B ARGININE BROTHK955143RPR LIQUID CONTROLSK955136RPR CARD TEST KITK961818GENTAMICIN DISK (120MCG)

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Related Devices (Code: JTN)

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.

K262113HardyDisk AST Tebipenem 10µg (TBP10)Hardy DiagnosticsK261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics

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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