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FDA 510(k)

ICON READER

K-Number: K862956 · 1986-08-19

ApplicantHybritech, Inc.
Decision Date1986-08-19
Product CodeJQT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ICON READER is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862956. The device is classified under product code JQT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICON READER?

ICON READER is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Hybritech, Inc.. The 510(k) number is K862956.

When did ICON READER receive FDA 510(k) clearance?

ICON READER received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862956.

Who is the listed applicant for ICON READER?

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 ICON READER?

The FDA product code for ICON READER is JQT.

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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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Related Devices (Code: JQT)

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.

K111356ASIMANAGER - ATArlington Scientific, Inc.K944185ISOSCANIsolab, Inc.K915332MODEL 795 FLUOROMETER/DENSITOMETERCiba Corning Diagnostics Corp.K885254TARGET READERV-Tech, Inc.K860645ELECTROPHORESIS DATA CENTER (EDC)Helena LaboratoriesK853734APOLLO DENSITOMETERAstral Medical Systems

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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