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FDA 510(k)

#2002 MANNITOL SALT AGAR

K-Number: K820799 · 1982-04-08

ApplicantBiomedica, Inc.
Decision Date1982-04-08
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

#2002 MANNITOL SALT AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Biomedica, Inc.. It received FDA 510(k) clearance on 1982-04-08 under 510(k) number K820799. 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 #2002 MANNITOL SALT AGAR?

#2002 MANNITOL SALT AGAR is a medical device that received FDA 510(k) clearance on 1982-04-08. The listed applicant is Biomedica, Inc.. The 510(k) number is K820799.

When did #2002 MANNITOL SALT AGAR receive FDA 510(k) clearance?

#2002 MANNITOL SALT AGAR received FDA 510(k) clearance on 1982-04-08, under 510(k) number K820799.

Who is the listed applicant for #2002 MANNITOL SALT AGAR?

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

What is the FDA product code for #2002 MANNITOL SALT AGAR?

The FDA product code for #2002 MANNITOL SALT AGAR is JSJ.

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Other records listing Biomedica, 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.

K820793#1904L MUELLER HINTON W/5% SHEEP BLOODK820803#2003 MYCOBIOTIC AGARK820809#2008 SIMMONS CITRATEK820802#2009 BIGGY AGARK820800#2006 SALMONELLA SHIGELLA AGARK820794#19012 CHOCOLATE MUELLER HINTON-150X15MM

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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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