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FDA 510(k)

ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS

K-Number: K973583 · 1997-11-12

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1997-11-12
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K973583. 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 ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS?

ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K973583.

When did ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS receive FDA 510(k) clearance?

ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS received FDA 510(k) clearance on 1997-11-12, under 510(k) number K973583.

Who is the listed applicant for ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS?

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

What is the FDA product code for ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS?

The FDA product code for ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS is KLS.

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Other records listing Schiapparelli Biosystems, Inc. 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.

K991733ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSK981377ACE T4 REAGENT T4 CALIBRATORSK981375ACE T UPTAKE REAGENT TU CALIBRATORSK973581ACE VALPROIC ACID REAGENT, AED CALIBRATORSK973582ACE PRIMIDONE REAGENT, AED CALIBRATORSK973536ACE PHENOBARBITAL REAGENT/AED CALIBRATORS

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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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