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FDA 510(k)

HELENA THROMBOPLASTIN REAGENT

K-Number: K892050 · 1989-06-07

ApplicantHelena Laboratories
Decision Date1989-06-07
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA THROMBOPLASTIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-06-07 under 510(k) number K892050. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA THROMBOPLASTIN REAGENT?

HELENA THROMBOPLASTIN REAGENT is a medical device that received FDA 510(k) clearance on 1989-06-07. The listed applicant is Helena Laboratories. The 510(k) number is K892050.

When did HELENA THROMBOPLASTIN REAGENT receive FDA 510(k) clearance?

HELENA THROMBOPLASTIN REAGENT received FDA 510(k) clearance on 1989-06-07, under 510(k) number K892050.

Who is the listed applicant for HELENA THROMBOPLASTIN REAGENT?

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 THROMBOPLASTIN REAGENT?

The FDA product code for HELENA THROMBOPLASTIN REAGENT is GJS.

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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: GJS)

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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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