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FDA 510(k)

BEHRING POLAROID OPUS THEOPHYLLINE

K-Number: K885044 · 1988-12-29

ApplicantPb Diagnostic Systems, Inc.
Decision Date1988-12-29
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BEHRING POLAROID OPUS THEOPHYLLINE is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1988-12-29 under 510(k) number K885044. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEHRING POLAROID OPUS THEOPHYLLINE?

BEHRING POLAROID OPUS THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 1988-12-29. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K885044.

When did BEHRING POLAROID OPUS THEOPHYLLINE receive FDA 510(k) clearance?

BEHRING POLAROID OPUS THEOPHYLLINE received FDA 510(k) clearance on 1988-12-29, under 510(k) number K885044.

Who is the listed applicant for BEHRING POLAROID OPUS THEOPHYLLINE?

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

What is the FDA product code for BEHRING POLAROID OPUS THEOPHYLLINE?

The FDA product code for BEHRING POLAROID OPUS THEOPHYLLINE is KLS.

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Other records listing Pb Diagnostic Systems, Inc. as applicant

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K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK933389OPUS CMV-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPA

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Related Devices (Code: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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