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FDA 510(k)

ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY

K-Number: K823370 · 1982-12-03

ApplicantSyva Co.
Decision Date1982-12-03
Product CodeKJI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVANCE TM EMIT(R) & TM AMIKACIN 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 1982-12-03 under 510(k) number K823370. The device is classified under product code KJI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY?

ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Syva Co.. The 510(k) number is K823370.

When did ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY receive FDA 510(k) clearance?

ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823370.

Who is the listed applicant for ADVANCE TM EMIT(R) & TM AMIKACIN 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 ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY?

The FDA product code for ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY is KJI.

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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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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Related Devices (Code: KJI)

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.

K832769AMES TDA KANAMYCIN TEST-CONTROL SERUMMiles Laboratories, Inc.K823062KENAMYCIN FLUORESCENT IMMUNOASSAY FIAAmerican Diagnostic Corp.K822808TDX KENAMYCINAbbott LaboratoriesK782125RIA KIT, KANAMYCINDiagnostic Products Corp.K772038KANAMYCIN RIAMonitor Science Corp.

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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