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FDA 510(k)

ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL

K-Number: K871229 · 1987-06-26

ApplicantMicroscan Div. Baxter Healthcare Corp.
Decision Date1987-06-26
Product CodeGOD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL is the device name listed in this FDA 510(k) record. The listed applicant is Microscan Div. Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1987-06-26 under 510(k) number K871229. The device is classified under product code GOD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL?

ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL is a medical device that received FDA 510(k) clearance on 1987-06-26. The listed applicant is Microscan Div. Baxter Healthcare Corp.. The 510(k) number is K871229.

When did ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL receive FDA 510(k) clearance?

ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL received FDA 510(k) clearance on 1987-06-26, under 510(k) number K871229.

Who is the listed applicant for ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL?

The FDA 510(k) record lists Microscan Div. Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL?

The FDA product code for ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL is GOD.

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Other records listing Microscan Div. Baxter Healthcare Corp. 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.

K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3K871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AK871228ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2K871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA BK871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1K871230ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS

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Related Devices (Code: GOD)

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.

K110722RPS ADENO DETECTOR PLUSRapid Pathogen Screening, Inc.K052092RPS ADENO DETECTORRapid Pathogen ScreeningK990630SAS ADENO TESTSa Scientific, Inc.K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMImmunoprobe, Inc.K881894ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)Cambridge Bioscience Corp.K873082ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TESTCambridge Bioscience Corp.

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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