FDA 510(k)

.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)

K-Number: K791476 · 1979-09-04

ApplicantIsle Media and Sterile Products, Inc.

Decision Date1979-09-04

Product CodeJSF

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

.E.C MEDIUM (ESCHERICHIA COLI MEDIUM) 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 1979-09-04 under 510(k) number K791476. The device is classified under product code JSF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the .E.C MEDIUM (ESCHERICHIA COLI MEDIUM)?

.E.C MEDIUM (ESCHERICHIA COLI MEDIUM) is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Isle Media and Sterile Products, Inc.. The 510(k) number is K791476.

When did .E.C MEDIUM (ESCHERICHIA COLI MEDIUM) receive FDA 510(k) clearance?

.E.C MEDIUM (ESCHERICHIA COLI MEDIUM) received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791476.

Who is the listed applicant for .E.C MEDIUM (ESCHERICHIA COLI MEDIUM)?

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 .E.C MEDIUM (ESCHERICHIA COLI MEDIUM)?

The FDA product code for .E.C MEDIUM (ESCHERICHIA COLI MEDIUM) is JSF.

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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: JSF)

K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860Lakewood Biochemical Co., Inc.K880126LAURYL TRYPTOSE BROTHHardy Media K880119MOELLERS DECARBOXYLASE, ONITHINEHardy Media K880120MOELLERS DECARBOXYLASE, LYSINEHardy Media K880139ONPG TEST REAGENTHardy Media K880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy Media

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.