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FDA 510(k)

BECKMAN ANTITHROMBIN III REAGENT KIT

K-Number: K901977 · 1990-08-06

ApplicantBeckman Instruments, Inc.
Decision Date1990-08-06
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BECKMAN ANTITHROMBIN III REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1990-08-06 under 510(k) number K901977. 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 BECKMAN ANTITHROMBIN III REAGENT KIT?

BECKMAN ANTITHROMBIN III REAGENT KIT is a medical device that received FDA 510(k) clearance on 1990-08-06. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K901977.

When did BECKMAN ANTITHROMBIN III REAGENT KIT receive FDA 510(k) clearance?

BECKMAN ANTITHROMBIN III REAGENT KIT received FDA 510(k) clearance on 1990-08-06, under 510(k) number K901977.

Who is the listed applicant for BECKMAN ANTITHROMBIN III REAGENT KIT?

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

What is the FDA product code for BECKMAN ANTITHROMBIN III REAGENT KIT?

The FDA product code for BECKMAN ANTITHROMBIN III REAGENT KIT is JBQ.

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Other records listing Beckman Instruments, Inc. as applicant

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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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