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FDA 510(k)

THEOPHYLLINE TEST KIT REF. #A874799

K-Number: K880291 · 1988-03-24

ApplicantPhotec Diagnostics, Inc.
Decision Date1988-03-24
Product CodeLCA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THEOPHYLLINE TEST KIT REF. #A874799 is the device name listed in this FDA 510(k) record. The listed applicant is Photec Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K880291. The device is classified under product code LCA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEOPHYLLINE TEST KIT REF. #A874799?

THEOPHYLLINE TEST KIT REF. #A874799 is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K880291.

When did THEOPHYLLINE TEST KIT REF. #A874799 receive FDA 510(k) clearance?

THEOPHYLLINE TEST KIT REF. #A874799 received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880291.

Who is the listed applicant for THEOPHYLLINE TEST KIT REF. #A874799?

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

What is the FDA product code for THEOPHYLLINE TEST KIT REF. #A874799?

The FDA product code for THEOPHYLLINE TEST KIT REF. #A874799 is LCA.

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Related Devices (Code: LCA)

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.

K833789PHASE II THEOPHYLLINE RADIOIMMUNOASSAYMedical & Scientific Designs, Inc.K821862QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.Kallestad Laboratories, Inc.K821347BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.Bioclinical Corp.K792062THEOPHYLLINE RIASSAYRia Diagnostics

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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