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FDA 510(k)

MEDIA FOR IN-VITRO DIAGNOSTIC USE

K-Number: K820863 · 1982-04-16

ApplicantIsle Media and Sterile Products, Inc.
Decision Date1982-04-16
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MEDIA FOR IN-VITRO DIAGNOSTIC USE 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 1982-04-16 under 510(k) number K820863. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIA FOR IN-VITRO DIAGNOSTIC USE?

MEDIA FOR IN-VITRO DIAGNOSTIC USE is a medical device that received FDA 510(k) clearance on 1982-04-16. The listed applicant is Isle Media and Sterile Products, Inc.. The 510(k) number is K820863.

When did MEDIA FOR IN-VITRO DIAGNOSTIC USE receive FDA 510(k) clearance?

MEDIA FOR IN-VITRO DIAGNOSTIC USE received FDA 510(k) clearance on 1982-04-16, under 510(k) number K820863.

Who is the listed applicant for MEDIA FOR IN-VITRO DIAGNOSTIC USE?

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 MEDIA FOR IN-VITRO DIAGNOSTIC USE?

The FDA product code for MEDIA FOR IN-VITRO DIAGNOSTIC USE is JSJ.

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Other records listing Isle Media and Sterile Products, 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.

K831671MODIFIED SOYBEAN CASEIN DIGEST BROTHK821218CAMPY-S AGARK812796ANAEROBIC CNA BLOOD AGARK812798MOTILITY GI MEDIUMK812795ANAEROBIC BLOOD AGARK812797SCHAEDLER AGARS

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Related Devices (Code: JSJ)

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.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia Manufacturers, 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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