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FDA 510(k)

CI-TROL HEPARIN CONTROLS, LOW/HIGH

K-Number: K812424 · 1981-10-02

ApplicantAmerican Dade
Decision Date1981-10-02
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CI-TROL HEPARIN CONTROLS, LOW/HIGH is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812424. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CI-TROL HEPARIN CONTROLS, LOW/HIGH?

CI-TROL HEPARIN CONTROLS, LOW/HIGH is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is American Dade. The 510(k) number is K812424.

When did CI-TROL HEPARIN CONTROLS, LOW/HIGH receive FDA 510(k) clearance?

CI-TROL HEPARIN CONTROLS, LOW/HIGH received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812424.

Who is the listed applicant for CI-TROL HEPARIN CONTROLS, LOW/HIGH?

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

What is the FDA product code for CI-TROL HEPARIN CONTROLS, LOW/HIGH?

The FDA product code for CI-TROL HEPARIN CONTROLS, LOW/HIGH is KFF.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: KFF)

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.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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