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FDA 510(k)

CEDIA THEOPHYLLINE ASSAY

K-Number: K961462 · 1996-06-27

ApplicantBoehringer Mannheim Corp.
Decision Date1996-06-27
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA THEOPHYLLINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1996-06-27 under 510(k) number K961462. 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 CEDIA THEOPHYLLINE ASSAY?

CEDIA THEOPHYLLINE ASSAY is a medical device that received FDA 510(k) clearance on 1996-06-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K961462.

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

CEDIA THEOPHYLLINE ASSAY received FDA 510(k) clearance on 1996-06-27, under 510(k) number K961462.

Who is the listed applicant for CEDIA THEOPHYLLINE ASSAY?

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

What is the FDA product code for CEDIA THEOPHYLLINE ASSAY?

The FDA product code for CEDIA THEOPHYLLINE ASSAY is KLS.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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