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FDA 510(k)

GDS ENZYMATIC THEOPHYLLINE REAGENT

K-Number: K891761 · 1989-05-16

ApplicantGds Diagnostics
Decision Date1989-05-16
Product CodeLCY
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GDS ENZYMATIC THEOPHYLLINE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gds Diagnostics. It received FDA 510(k) clearance on 1989-05-16 under 510(k) number K891761. 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 GDS ENZYMATIC THEOPHYLLINE REAGENT?

GDS ENZYMATIC THEOPHYLLINE REAGENT is a medical device that received FDA 510(k) clearance on 1989-05-16. The listed applicant is Gds Diagnostics. The 510(k) number is K891761.

When did GDS ENZYMATIC THEOPHYLLINE REAGENT receive FDA 510(k) clearance?

GDS ENZYMATIC THEOPHYLLINE REAGENT received FDA 510(k) clearance on 1989-05-16, under 510(k) number K891761.

Who is the listed applicant for GDS ENZYMATIC THEOPHYLLINE REAGENT?

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

What is the FDA product code for GDS ENZYMATIC THEOPHYLLINE REAGENT?

The FDA product code for GDS ENZYMATIC THEOPHYLLINE REAGENT is LCY.

Related Clinical Trials

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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Other records listing Gds Diagnostics 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.

K931257ACETASITEK910881CONTROL AND LINEARITYK910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

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.

K780442THEOPHYLLINE ASSAY TO THE GEMSAECSyva Co.K780441THEOPHYLLINE ASSAY TO THE CENTRIFICHEMSyva 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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