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FDA 510(k)

HEPAQUANT

K-Number: K813011 · 1982-01-26

ApplicantStreck Laboratories, Inc.
Decision Date1982-01-26
Product CodeJOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPAQUANT is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 1982-01-26 under 510(k) number K813011. The device is classified under product code JOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPAQUANT?

HEPAQUANT is a medical device that received FDA 510(k) clearance on 1982-01-26. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K813011.

When did HEPAQUANT receive FDA 510(k) clearance?

HEPAQUANT received FDA 510(k) clearance on 1982-01-26, under 510(k) number K813011.

Who is the listed applicant for HEPAQUANT?

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

What is the FDA product code for HEPAQUANT?

The FDA product code for HEPAQUANT is JOX.

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Other records listing Streck Laboratories, Inc. as applicant

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Related Devices (Code: JOX)

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.

K111339HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)Medtronic, Inc.K102953HEPARIN DOSE RESPONSE CARTRIDGEMedtronic, Inc.K101271HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XXMedtronic, Inc.K051040HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic Perfusion SystemsK043080HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic VascularK042070HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20Medtronic Vascular

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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