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FDA 510(k)

HELENA PLASMINOGEN QUIPLATE PROCEDURE

K-Number: K811777 · 1981-07-02

ApplicantHelena Laboratories
Decision Date1981-07-02
Product CodeDDX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HELENA PLASMINOGEN QUIPLATE PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K811777. The device is classified under product code DDX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA PLASMINOGEN QUIPLATE PROCEDURE?

HELENA PLASMINOGEN QUIPLATE PROCEDURE is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Helena Laboratories. The 510(k) number is K811777.

When did HELENA PLASMINOGEN QUIPLATE PROCEDURE receive FDA 510(k) clearance?

HELENA PLASMINOGEN QUIPLATE PROCEDURE received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811777.

Who is the listed applicant for HELENA PLASMINOGEN QUIPLATE PROCEDURE?

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

What is the FDA product code for HELENA PLASMINOGEN QUIPLATE PROCEDURE?

The FDA product code for HELENA PLASMINOGEN QUIPLATE PROCEDURE is DDX.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: DDX)

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.

K941346PLASMINOGEN RID TEST KITThe Binding Site, Ltd.K884766BERICHROM(R) PLASMINOGENBehring Diagnostics, Inc.K864212IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory COK854572COATEST PLASMINOGENKabivitrum, Inc.K850410GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAYWarner-Lambert Co.K832591DIACROM *PLGWellcome Diagnostics

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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