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FDA 510(k)

ANTITHROMBIN III SERUM, ANTI-HUMAN

K-Number: K781026 · 1978-08-10

ApplicantIcl Scientific
Decision Date1978-08-10
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANTITHROMBIN III SERUM, ANTI-HUMAN is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1978-08-10 under 510(k) number K781026. 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 SERUM, ANTI-HUMAN?

ANTITHROMBIN III SERUM, ANTI-HUMAN is a medical device that received FDA 510(k) clearance on 1978-08-10. The listed applicant is Icl Scientific. The 510(k) number is K781026.

When did ANTITHROMBIN III SERUM, ANTI-HUMAN receive FDA 510(k) clearance?

ANTITHROMBIN III SERUM, ANTI-HUMAN received FDA 510(k) clearance on 1978-08-10, under 510(k) number K781026.

Who is the listed applicant for ANTITHROMBIN III SERUM, ANTI-HUMAN?

The FDA 510(k) record lists Icl Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTITHROMBIN III SERUM, ANTI-HUMAN?

The FDA product code for ANTITHROMBIN III SERUM, ANTI-HUMAN is JBQ.

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Other records listing Icl Scientific 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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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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