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FDA 510(k)

SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY

K-Number: K820187 · 1982-02-12

ApplicantSyva Co.
Decision Date1982-02-12
Product CodeLES
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820187. The device is classified under product code LES. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY?

SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Syva Co.. The 510(k) number is K820187.

When did SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY receive FDA 510(k) clearance?

SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820187.

Who is the listed applicant for SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY?

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 SYS. EMIT,(R)-AED(R) PHENY?

The FDA product code for SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY is LES.

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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: LES)

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.

K865102IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTSSclavo, Inc.K844990SYVA ADVANCE EMIT PHENYTOIN ASSAYSyva Co.K831154STRATUS PHENYTOIN FLUOROMETRIC ENZYMEAmerican DadeK813538PHENYTOIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.K811025AMES TDA TM PHENYTOIN TESTMiles Laboratories, Inc.K801736AMES TDA TM PHENYTOIN TESTMiles Laboratories, Inc.

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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