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FDA 510(k)

PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS

K-Number: K932685 · 1993-09-24

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-09-24
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PARAMAX(R) THEOPHYLLINE 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 1993-09-24 under 510(k) number K932685. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS?

PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K932685.

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

PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS received FDA 510(k) clearance on 1993-09-24, under 510(k) number K932685.

Who is the listed applicant for PARAMAX(R) THEOPHYLLINE 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(R) THEOPHYLLINE REAGENT AND CALIBRATORS?

The FDA product code for PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS is KLS.

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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: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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