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FDA 510(k)

THROMBO SCREEN QUANTITATIVE HEPARIN ASSA

K-Number: K770722 · 1977-07-11

ApplicantBay Area Hema. Onco. Clinic. & Res. L
Decision Date1977-07-11
Product CodeJBR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBO SCREEN QUANTITATIVE HEPARIN ASSA 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 1977-07-11 under 510(k) number K770722. The device is classified under product code JBR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBO SCREEN QUANTITATIVE HEPARIN ASSA?

THROMBO SCREEN QUANTITATIVE HEPARIN ASSA is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Bay Area Hema. Onco. Clinic. & Res. L. The 510(k) number is K770722.

When did THROMBO SCREEN QUANTITATIVE HEPARIN ASSA receive FDA 510(k) clearance?

THROMBO SCREEN QUANTITATIVE HEPARIN ASSA received FDA 510(k) clearance on 1977-07-11, under 510(k) number K770722.

Who is the listed applicant for THROMBO SCREEN QUANTITATIVE HEPARIN ASSA?

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 QUANTITATIVE HEPARIN ASSA?

The FDA product code for THROMBO SCREEN QUANTITATIVE HEPARIN ASSA is JBR.

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.

K771678THROMBO-SCREEN PLATELET ADHESIONK770394THROMBO-SCREEN AT-111 KITK770395THROMBO-CETIN (RISTOCETIN)

Related Devices (Code: JBR)

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.

K925452DADE HEPZYMEBaxter Diagnostics, Inc.K874373PT PRO-CLOTProbe-Tek, Inc.

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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