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FDA 510(k)

ACE PHENOBARBITAL REAGENT/AED CALIBRATORS

K-Number: K973536 · 1997-11-06

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1997-11-06
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACE PHENOBARBITAL REAGENT/AED 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 1997-11-06 under 510(k) number K973536. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE PHENOBARBITAL REAGENT/AED CALIBRATORS?

ACE PHENOBARBITAL REAGENT/AED CALIBRATORS is a medical device that received FDA 510(k) clearance on 1997-11-06. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K973536.

When did ACE PHENOBARBITAL REAGENT/AED CALIBRATORS receive FDA 510(k) clearance?

ACE PHENOBARBITAL REAGENT/AED CALIBRATORS received FDA 510(k) clearance on 1997-11-06, under 510(k) number K973536.

Who is the listed applicant for ACE PHENOBARBITAL REAGENT/AED 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 PHENOBARBITAL REAGENT/AED CALIBRATORS?

The FDA product code for ACE PHENOBARBITAL REAGENT/AED CALIBRATORS is DLJ.

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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 CALIBRATORSK973583ACE THEOPHYLLINE REAGENT, THEO CALIBRATORSK973582ACE PRIMIDONE REAGENT, AED CALIBRATORS

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Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)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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