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FDA 510(k)

ENCORE FERRITIN REAGENT

K-Number: K850680 · 1985-03-21

ApplicantHybritech, Inc.
Decision Date1985-03-21
Product CodeJMB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ENCORE FERRITIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1985-03-21 under 510(k) number K850680. The device is classified under product code JMB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCORE FERRITIN REAGENT?

ENCORE FERRITIN REAGENT is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is Hybritech, Inc.. The 510(k) number is K850680.

When did ENCORE FERRITIN REAGENT receive FDA 510(k) clearance?

ENCORE FERRITIN REAGENT received FDA 510(k) clearance on 1985-03-21, under 510(k) number K850680.

Who is the listed applicant for ENCORE FERRITIN REAGENT?

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

What is the FDA product code for ENCORE FERRITIN REAGENT?

The FDA product code for ENCORE FERRITIN REAGENT is JMB.

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Other records listing Hybritech, Inc. 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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