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FDA 510(k)

SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY

K-Number: K820285 · 1982-02-18

ApplicantSyva Co.
Decision Date1982-02-18
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-02-18 under 510(k) number K820285. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY?

SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY is a medical device that received FDA 510(k) clearance on 1982-02-18. The listed applicant is Syva Co.. The 510(k) number is K820285.

When did SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY receive FDA 510(k) clearance?

SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY received FDA 510(k) clearance on 1982-02-18, under 510(k) number K820285.

Who is the listed applicant for SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY?

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 SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY?

The FDA product code for SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY is LCQ.

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Other records listing Syva Co. 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.

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Related Devices (Code: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott Laboratories

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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