Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

#2003 MYCOBIOTIC AGAR

K-Number: K820803 · 1982-04-08

Decision Date1982-04-08
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

#2003 MYCOBIOTIC 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 K820803. 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 #2003 MYCOBIOTIC AGAR?

#2003 MYCOBIOTIC 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 K820803.

When did #2003 MYCOBIOTIC AGAR receive FDA 510(k) clearance?

#2003 MYCOBIOTIC AGAR received FDA 510(k) clearance on 1982-04-08, under 510(k) number K820803.

Who is the listed applicant for #2003 MYCOBIOTIC 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 #2003 MYCOBIOTIC AGAR?

The FDA product code for #2003 MYCOBIOTIC AGAR is JSJ.

Related Clinical Trials

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.

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.

View all 19 devices →

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.

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.

↑