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FDA 510(k)

ACE T4 REAGENT T4 CALIBRATORS

K-Number: K981377 · 1998-06-10

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1998-06-10
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE T4 REAGENT T4 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 1998-06-10 under 510(k) number K981377. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE T4 REAGENT T4 CALIBRATORS?

ACE T4 REAGENT T4 CALIBRATORS is a medical device that received FDA 510(k) clearance on 1998-06-10. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K981377.

When did ACE T4 REAGENT T4 CALIBRATORS receive FDA 510(k) clearance?

ACE T4 REAGENT T4 CALIBRATORS received FDA 510(k) clearance on 1998-06-10, under 510(k) number K981377.

Who is the listed applicant for ACE T4 REAGENT T4 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 T4 REAGENT T4 CALIBRATORS?

The FDA product code for ACE T4 REAGENT T4 CALIBRATORS is KLI.

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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 CONTROLSK981375ACE T UPTAKE REAGENT TU CALIBRATORSK973581ACE VALPROIC ACID REAGENT, AED CALIBRATORSK973583ACE THEOPHYLLINE REAGENT, THEO CALIBRATORSK973582ACE PRIMIDONE REAGENT, AED CALIBRATORSK973536ACE PHENOBARBITAL REAGENT/AED CALIBRATORS

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Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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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