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FDA 510(k)

TODD HEWITT W/CNA (LIM BROTH)

K-Number: K871447 · 1987-05-13

ApplicantRemel Co.
Decision Date1987-05-13
Product CodeJSD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TODD HEWITT W/CNA (LIM BROTH) is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1987-05-13 under 510(k) number K871447. The device is classified under product code JSD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TODD HEWITT W/CNA (LIM BROTH)?

TODD HEWITT W/CNA (LIM BROTH) is a medical device that received FDA 510(k) clearance on 1987-05-13. The listed applicant is Remel Co.. The 510(k) number is K871447.

When did TODD HEWITT W/CNA (LIM BROTH) receive FDA 510(k) clearance?

TODD HEWITT W/CNA (LIM BROTH) received FDA 510(k) clearance on 1987-05-13, under 510(k) number K871447.

Who is the listed applicant for TODD HEWITT W/CNA (LIM BROTH)?

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

What is the FDA product code for TODD HEWITT W/CNA (LIM BROTH)?

The FDA product code for TODD HEWITT W/CNA (LIM BROTH) is JSD.

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JSD)

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.

K883075FASTIDIOUS INOCULUM BROTHBaxter Healthcare CorpK880107CAMPY BROTHHardy MediaK873324SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331Lakewood Biochemical Co., Inc.K873218BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802Lakewood Biochemical Co., Inc.K871640ALKALINE PEPTONE WATERBd Becton Dickinson Vacutainer Systems PreanalyticK870594T9802 TSB W/6.5% NACLLakewood Biochemical Co., 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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