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FDA 510(k)

EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO

K-Number: K820440 · 1982-03-15

ApplicantSyva Co.
Decision Date1982-03-15
Product CodeLDN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-03-15 under 510(k) number K820440. The device is classified under product code LDN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO?

EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO is a medical device that received FDA 510(k) clearance on 1982-03-15. The listed applicant is Syva Co.. The 510(k) number is K820440.

When did EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO receive FDA 510(k) clearance?

EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO received FDA 510(k) clearance on 1982-03-15, under 510(k) number K820440.

Who is the listed applicant for EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO?

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

What is the FDA product code for EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO?

The FDA product code for EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO is LDN.

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Other records listing Syva Co. as applicant

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Related Devices (Code: LDN)

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.

K840647AMIKACIN REAGENT TEST KITBeckman Instruments, Inc.K833546MODIFICATION OF EMIT AND AMIKACIN ASSAYSyva Co.

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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