FDA 510(k)

SELENITE CYSTINE BROTH

K-Number: K791471 · 1979-08-22

ApplicantIsle Media and Sterile Products, Inc.

Decision Date1979-08-22

Product CodeJSD

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SELENITE CYSTINE BROTH is the device name listed in this FDA 510(k) record. The listed applicant is Isle Media and Sterile Products, Inc.. It received FDA 510(k) clearance on 1979-08-22 under 510(k) number K791471. 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 SELENITE CYSTINE BROTH?

SELENITE CYSTINE BROTH is a medical device that received FDA 510(k) clearance on 1979-08-22. The listed applicant is Isle Media and Sterile Products, Inc.. The 510(k) number is K791471.

When did SELENITE CYSTINE BROTH receive FDA 510(k) clearance?

SELENITE CYSTINE BROTH received FDA 510(k) clearance on 1979-08-22, under 510(k) number K791471.

Who is the listed applicant for SELENITE CYSTINE BROTH?

The FDA 510(k) record lists Isle Media and Sterile Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELENITE CYSTINE BROTH?

The FDA product code for SELENITE CYSTINE BROTH is JSD.

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Other records listing Isle Media and Sterile Products, Inc. as applicant

K831671MODIFIED SOYBEAN CASEIN DIGEST BROTH K821218CAMPY-S AGAR K820863MEDIA FOR IN-VITRO DIAGNOSTIC USE K812796ANAEROBIC CNA BLOOD AGAR K812795ANAEROBIC BLOOD AGAR K812798MOTILITY GI MEDIUM

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Related Devices (Code: JSD)

K883075FASTIDIOUS INOCULUM BROTHBaxter Healthcare Corp K880107CAMPY BROTHHardy Media K873324SABOURAUD 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 Preanalytic K871447TODD HEWITT W/CNA (LIM BROTH)Remel Co.

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.