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FDA 510(k)

MURINE MONOCLONAL ANTI-ADENOVIRUS IGG

K-Number: K885310 · 1989-02-16

ApplicantWhittaker Bioproducts, Inc.
Decision Date1989-02-16
Product CodeGNY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MURINE MONOCLONAL ANTI-ADENOVIRUS IGG is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1989-02-16 under 510(k) number K885310. The device is classified under product code GNY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MURINE MONOCLONAL ANTI-ADENOVIRUS IGG?

MURINE MONOCLONAL ANTI-ADENOVIRUS IGG is a medical device that received FDA 510(k) clearance on 1989-02-16. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K885310.

When did MURINE MONOCLONAL ANTI-ADENOVIRUS IGG receive FDA 510(k) clearance?

MURINE MONOCLONAL ANTI-ADENOVIRUS IGG received FDA 510(k) clearance on 1989-02-16, under 510(k) number K885310.

Who is the listed applicant for MURINE MONOCLONAL ANTI-ADENOVIRUS IGG?

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

What is the FDA product code for MURINE MONOCLONAL ANTI-ADENOVIRUS IGG?

The FDA product code for MURINE MONOCLONAL ANTI-ADENOVIRUS IGG is GNY.

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Other records listing Whittaker Bioproducts, Inc. as applicant

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Related Devices (Code: GNY)

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.

K922801RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK770807ADENOVIRUS-GROUP FA LABELLED (8-651 RF)Flow Laboratories, Inc.K770811ADENOVIRUS GROUP-FA LABELLED PRESERUMFlow Laboratories, Inc.

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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