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FDA 510(k)

STRATUS THEOPHYLLINE ASSAY

K-Number: K832965 · 1983-12-30

ApplicantAmerican Dade
Decision Date1983-12-30
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS THEOPHYLLINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-12-30 under 510(k) number K832965. 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 STRATUS THEOPHYLLINE ASSAY?

STRATUS THEOPHYLLINE ASSAY is a medical device that received FDA 510(k) clearance on 1983-12-30. The listed applicant is American Dade. The 510(k) number is K832965.

When did STRATUS THEOPHYLLINE ASSAY receive FDA 510(k) clearance?

STRATUS THEOPHYLLINE ASSAY received FDA 510(k) clearance on 1983-12-30, under 510(k) number K832965.

Who is the listed applicant for STRATUS THEOPHYLLINE ASSAY?

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

What is the FDA product code for STRATUS THEOPHYLLINE ASSAY?

The FDA product code for STRATUS THEOPHYLLINE ASSAY is KLS.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

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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