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FDA 510(k)

ICON STREP B IMMUNOENZYMETRIC ASSAY

K-Number: K902991 · 1990-10-03

ApplicantHybritech, Inc.
Decision Date1990-10-03
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ICON STREP B IMMUNOENZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1990-10-03 under 510(k) number K902991. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICON STREP B IMMUNOENZYMETRIC ASSAY?

ICON STREP B IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1990-10-03. The listed applicant is Hybritech, Inc.. The 510(k) number is K902991.

When did ICON STREP B IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

ICON STREP B IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1990-10-03, under 510(k) number K902991.

Who is the listed applicant for ICON STREP B IMMUNOENZYMETRIC ASSAY?

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 STREP B IMMUNOENZYMETRIC ASSAY?

The FDA product code for ICON STREP B IMMUNOENZYMETRIC ASSAY is GTY.

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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: GTY)

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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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