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FDA 510(k)

THROMBO-SCREEN PLATELET ADHESION

K-Number: K771678 · 1977-11-22

ApplicantBay Area Hema. Onco. Clinic. & Res. L
Decision Date1977-11-22
Product CodeJBZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBO-SCREEN PLATELET ADHESION is the device name listed in this FDA 510(k) record. The listed applicant is Bay Area Hema. Onco. Clinic. & Res. L. It received FDA 510(k) clearance on 1977-11-22 under 510(k) number K771678. The device is classified under product code JBZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBO-SCREEN PLATELET ADHESION?

THROMBO-SCREEN PLATELET ADHESION is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Bay Area Hema. Onco. Clinic. & Res. L. The 510(k) number is K771678.

When did THROMBO-SCREEN PLATELET ADHESION receive FDA 510(k) clearance?

THROMBO-SCREEN PLATELET ADHESION received FDA 510(k) clearance on 1977-11-22, under 510(k) number K771678.

Who is the listed applicant for THROMBO-SCREEN PLATELET ADHESION?

The FDA 510(k) record lists Bay Area Hema. Onco. Clinic. & Res. L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THROMBO-SCREEN PLATELET ADHESION?

The FDA product code for THROMBO-SCREEN PLATELET ADHESION is JBZ.

Related Clinical Trials

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.

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Other records listing Bay Area Hema. Onco. Clinic. & Res. L 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.

K770722THROMBO SCREEN QUANTITATIVE HEPARIN ASSAK770394THROMBO-SCREEN AT-111 KITK770395THROMBO-CETIN (RISTOCETIN)

Related Devices (Code: JBZ)

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.

K800037PLATELET RETENTION (ADHESION) COLUMNSHemometrixK771523LATELET RETENTION COLUMNBd Becton Dickinson Vacutainer Systems Preanalytic

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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