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FDA 510(k)

CEFUROXIME 30MCG. SUSCEP DISK

K-Number: K832653 · 1983-10-14

ApplicantGeneral Diagnostics
Decision Date1983-10-14
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFUROXIME 30MCG. SUSCEP 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 1983-10-14 under 510(k) number K832653. 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 CEFUROXIME 30MCG. SUSCEP DISK?

CEFUROXIME 30MCG. SUSCEP DISK is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is General Diagnostics. The 510(k) number is K832653.

When did CEFUROXIME 30MCG. SUSCEP DISK receive FDA 510(k) clearance?

CEFUROXIME 30MCG. SUSCEP DISK received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832653.

Who is the listed applicant for CEFUROXIME 30MCG. SUSCEP 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 CEFUROXIME 30MCG. SUSCEP DISK?

The FDA product code for CEFUROXIME 30MCG. SUSCEP DISK is JTN.

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Other records listing General Diagnostics as applicant

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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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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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