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FDA 510(k)

MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK

K-Number: K812993 · 1981-11-10

ApplicantGeneral Diagnostics
Decision Date1981-11-10
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K812993. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK?

MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is General Diagnostics. The 510(k) number is K812993.

When did MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK receive FDA 510(k) clearance?

MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK received FDA 510(k) clearance on 1981-11-10, under 510(k) number K812993.

Who is the listed applicant for MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK?

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

What is the FDA product code for MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK?

The FDA product code for MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK is JTN.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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Related Devices (Code: JTN)

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.

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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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