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FDA 510(k)

REMEL SPECTRA MRSA

K-Number: K092407 · 2010-10-08

ApplicantRemel, Inc.
Decision Date2010-10-08
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL SPECTRA MRSA is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2010-10-08 under 510(k) number K092407. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEL SPECTRA MRSA?

REMEL SPECTRA MRSA is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is Remel, Inc.. The 510(k) number is K092407.

When did REMEL SPECTRA MRSA receive FDA 510(k) clearance?

REMEL SPECTRA MRSA received FDA 510(k) clearance on 2010-10-08, under 510(k) number K092407.

Who is the listed applicant for REMEL SPECTRA MRSA?

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

What is the FDA product code for REMEL SPECTRA MRSA?

The FDA product code for REMEL SPECTRA MRSA is JSO.

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Other records listing Remel, Inc. 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.

K162620Remel Spectra ESBLK131804REMEL XPECT FLU A&BK072827RPMI 1640 AGAR W/MOPS AND 2% GLUCOSEK041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BK033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYK031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

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Related Devices (Code: JSO)

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.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID MRSAbioMerieux, Inc.

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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