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FDA 510(k)

THROMBOPLASTIN-R REAGENT

K-Number: K853986 · 1985-11-12

ApplicantAmerican Dade
Decision Date1985-11-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOPLASTIN-R REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K853986. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOPLASTIN-R REAGENT?

THROMBOPLASTIN-R REAGENT is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is American Dade. The 510(k) number is K853986.

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

THROMBOPLASTIN-R REAGENT received FDA 510(k) clearance on 1985-11-12, under 510(k) number K853986.

Who is the listed applicant for THROMBOPLASTIN-R REAGENT?

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

What is the FDA product code for THROMBOPLASTIN-R REAGENT?

The FDA product code for THROMBOPLASTIN-R REAGENT is JPA.

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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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