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FDA 510(k)

ANTITHROMBIN III CHROMOGENIC ASSAY

K-Number: K936196 · 1994-05-04

ApplicantBaxter Diagnostics, Inc.
Decision Date1994-05-04
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANTITHROMBIN III CHROMOGENIC ASSAY 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 1994-05-04 under 510(k) number K936196. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTITHROMBIN III CHROMOGENIC ASSAY?

ANTITHROMBIN III CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K936196.

When did ANTITHROMBIN III CHROMOGENIC ASSAY receive FDA 510(k) clearance?

ANTITHROMBIN III CHROMOGENIC ASSAY received FDA 510(k) clearance on 1994-05-04, under 510(k) number K936196.

Who is the listed applicant for ANTITHROMBIN III CHROMOGENIC ASSAY?

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 ANTITHROMBIN III CHROMOGENIC ASSAY?

The FDA product code for ANTITHROMBIN III CHROMOGENIC ASSAY is JBQ.

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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: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory 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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