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)

ENDO AGAR

K-Number: K811648 · 1981-07-02

ApplicantAcumedia Manufacturers, Inc.
Decision Date1981-07-02
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENDO 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 1981-07-02 under 510(k) number K811648. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO AGAR?

ENDO AGAR is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Acumedia Manufacturers, Inc.. The 510(k) number is K811648.

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

ENDO AGAR received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811648.

Who is the listed applicant for ENDO 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 ENDO AGAR?

The FDA product code for ENDO AGAR is JSI.

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.

K881534ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGARK881540FLO AGARK881544LITTMAN AGARK881561TERGITOL 7 BROTHK881575SELECTIVE STREPTOCOCCUS AGARK881569STUARTS TRANSPORT MEDIUM

View all 177 devices →

Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia 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.

↑