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FDA 510(k)

ACE PRIMIDONE REAGENT, AED CALIBRATORS

K-Number: K973582 · 1997-11-12

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

Device Summary

ACE PRIMIDONE 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 1997-11-12 under 510(k) number K973582. The device is classified under product code DJD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE PRIMIDONE REAGENT, AED CALIBRATORS?

ACE PRIMIDONE REAGENT, AED 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 K973582.

When did ACE PRIMIDONE REAGENT, AED CALIBRATORS receive FDA 510(k) clearance?

ACE PRIMIDONE REAGENT, AED CALIBRATORS received FDA 510(k) clearance on 1997-11-12, under 510(k) number K973582.

Who is the listed applicant for ACE PRIMIDONE 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 PRIMIDONE REAGENT, AED CALIBRATORS?

The FDA product code for ACE PRIMIDONE REAGENT, AED CALIBRATORS is DJD.

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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 CALIBRATORSK973536ACE PHENOBARBITAL REAGENT/AED CALIBRATORS

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Related Devices (Code: DJD)

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.

K910527EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONESyva Co.K840939EMIT QST PRIMIDONE ASSAYSyva Co.K832798MODIFICA-OF EMIT AED PRIMIDONE ASSAYSyva Co.K820138PRIMIDONE REAGENT TEST KITBeckman Instruments, Inc.K813597TDX PRIMIDONEAbbott LaboratoriesK802654AMES TDA PRIMIDONE TESTMiles Laboratories, 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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