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FDA 510(k)

IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN

K-Number: K831961 · 1983-08-11

ApplicantKent Laboratories, Inc.
Decision Date1983-08-11
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K831961. 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 IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN?

IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K831961.

When did IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN receive FDA 510(k) clearance?

IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN received FDA 510(k) clearance on 1983-08-11, under 510(k) number K831961.

Who is the listed applicant for IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN?

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

What is the FDA product code for IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN?

The FDA product code for IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN is JBQ.

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Other records listing Kent Laboratories, 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

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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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