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FDA 510(k)

PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS

K-Number: K935568 · 1994-03-11

ApplicantBaxter Diagnostics, Inc.
Decision Date1994-03-11
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS 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 1994-03-11 under 510(k) number K935568. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS?

PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K935568.

When did PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS receive FDA 510(k) clearance?

PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS received FDA 510(k) clearance on 1994-03-11, under 510(k) number K935568.

Who is the listed applicant for PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS?

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 PHENOBARBITAL REAGENT AND CALIBRATORS?

The FDA product code for PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS is DLZ.

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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: DLZ)

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.

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.

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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