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FDA 510(k)

10B ARGININE BROTH

K-Number: K961046 · 1996-09-18

ApplicantRemel, L.P.
Decision Date1996-09-18
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

10B ARGININE BROTH 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 1996-09-18 under 510(k) number K961046. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 10B ARGININE BROTH?

10B ARGININE BROTH is a medical device that received FDA 510(k) clearance on 1996-09-18. The listed applicant is Remel, L.P.. The 510(k) number is K961046.

When did 10B ARGININE BROTH receive FDA 510(k) clearance?

10B ARGININE BROTH received FDA 510(k) clearance on 1996-09-18, under 510(k) number K961046.

Who is the listed applicant for 10B ARGININE BROTH?

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 10B ARGININE BROTH?

The FDA product code for 10B ARGININE BROTH is JSM.

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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 KITK964421REMEL MEROPENEM 10UG SUSCEPTIBILITY DISKK955143RPR LIQUID CONTROLSK955136RPR CARD TEST KITK961818GENTAMICIN DISK (120MCG)

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Related Devices (Code: JSM)

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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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