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)

SCHAEDLER AGAR

K-Number: K811328 · 1981-05-28

Decision Date1981-05-28
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SCHAEDLER AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Acumedia Manufacturers, Inc.. It received FDA 510(k) clearance on 1981-05-28 under 510(k) number K811328. 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 SCHAEDLER AGAR?

SCHAEDLER AGAR is a medical device that received FDA 510(k) clearance on 1981-05-28. The listed applicant is Acumedia Manufacturers, Inc.. The 510(k) number is K811328.

When did SCHAEDLER AGAR receive FDA 510(k) clearance?

SCHAEDLER AGAR received FDA 510(k) clearance on 1981-05-28, under 510(k) number K811328.

Who is the listed applicant for SCHAEDLER AGAR?

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

What is the FDA product code for SCHAEDLER AGAR?

The FDA product code for SCHAEDLER 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 Acumedia Manufacturers, 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 177 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.

↑