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FDA 510(k)

PARAMAX(R) PHENYTOIN REAGENT

K-Number: K932686 · 1993-11-26

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-11-26
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PARAMAX(R) PHENYTOIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-11-26 under 510(k) number K932686. 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 PARAMAX(R) PHENYTOIN REAGENT?

PARAMAX(R) PHENYTOIN REAGENT is a medical device that received FDA 510(k) clearance on 1993-11-26. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K932686.

When did PARAMAX(R) PHENYTOIN REAGENT receive FDA 510(k) clearance?

PARAMAX(R) PHENYTOIN REAGENT received FDA 510(k) clearance on 1993-11-26, under 510(k) number K932686.

Who is the listed applicant for PARAMAX(R) PHENYTOIN REAGENT?

The FDA 510(k) record lists Baxter Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAMAX(R) PHENYTOIN REAGENT?

The FDA product code for PARAMAX(R) PHENYTOIN REAGENT is DIP.

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Other records listing Baxter Diagnostics, 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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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