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FDA 510(k)

ACE PHENYTOIN REAGENT, AED CALIBRATORS

K-Number: K973414 · 1997-11-04

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1997-11-04
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACE PHENYTOIN 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 1997-11-04 under 510(k) number K973414. The device is classified under product code DIP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE PHENYTOIN REAGENT, AED CALIBRATORS?

ACE PHENYTOIN REAGENT, AED CALIBRATORS is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K973414.

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

ACE PHENYTOIN REAGENT, AED CALIBRATORS received FDA 510(k) clearance on 1997-11-04, under 510(k) number K973414.

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

The FDA product code for ACE PHENYTOIN REAGENT, AED CALIBRATORS is DIP.

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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: DIP)

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.

K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott LaboratoriesK063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OYK030428ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.K011393RANDOX PHENYTOINRandox Laboratories, Ltd.K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.

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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