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FDA 510(k)

THEOPHYLLINE ASSAY TO THE CENTRIFICHEM

K-Number: K780441 · 1978-04-12

ApplicantSyva Co.
Decision Date1978-04-12
Product CodeLCY
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THEOPHYLLINE ASSAY TO THE CENTRIFICHEM is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1978-04-12 under 510(k) number K780441. The device is classified under product code LCY. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEOPHYLLINE ASSAY TO THE CENTRIFICHEM?

THEOPHYLLINE ASSAY TO THE CENTRIFICHEM is a medical device that received FDA 510(k) clearance on 1978-04-12. The listed applicant is Syva Co.. The 510(k) number is K780441.

When did THEOPHYLLINE ASSAY TO THE CENTRIFICHEM receive FDA 510(k) clearance?

THEOPHYLLINE ASSAY TO THE CENTRIFICHEM received FDA 510(k) clearance on 1978-04-12, under 510(k) number K780441.

Who is the listed applicant for THEOPHYLLINE ASSAY TO THE CENTRIFICHEM?

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 THEOPHYLLINE ASSAY TO THE CENTRIFICHEM?

The FDA product code for THEOPHYLLINE ASSAY TO THE CENTRIFICHEM is LCY.

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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: LCY)

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.

K891761GDS ENZYMATIC THEOPHYLLINE REAGENTGds DiagnosticsK780442THEOPHYLLINE ASSAY TO THE GEMSAECSyva 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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