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FDA 510(k)

ACE(TM) CEDIA(R) PHENYTOIN ASSAY

K-Number: K944085 · 1994-12-28

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1994-12-28
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACE(TM) CEDIA(R) PHENYTOIN ASSAY 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 1994-12-28 under 510(k) number K944085. 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(TM) CEDIA(R) PHENYTOIN ASSAY?

ACE(TM) CEDIA(R) PHENYTOIN ASSAY is a medical device that received FDA 510(k) clearance on 1994-12-28. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K944085.

When did ACE(TM) CEDIA(R) PHENYTOIN ASSAY receive FDA 510(k) clearance?

ACE(TM) CEDIA(R) PHENYTOIN ASSAY received FDA 510(k) clearance on 1994-12-28, under 510(k) number K944085.

Who is the listed applicant for ACE(TM) CEDIA(R) PHENYTOIN ASSAY?

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(TM) CEDIA(R) PHENYTOIN ASSAY?

The FDA product code for ACE(TM) CEDIA(R) PHENYTOIN ASSAY is DIP.

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Other records listing Schiapparelli Biosystems, Inc. as applicant

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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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