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FDA 510(k)

ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2

K-Number: K871228 · 1987-06-26

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

Device Summary

ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 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 K871228. The device is classified under product code GQS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2?

ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 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 K871228.

When did ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 receive FDA 510(k) clearance?

ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 received FDA 510(k) clearance on 1987-06-26, under 510(k) number K871228.

Who is the listed applicant for ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2?

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 DETECT. OF PARAINFLUENZA TYPE 2?

The FDA product code for ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 is GQS.

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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 3K871229ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELLK871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AK871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA BK871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1K871230ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS

View all 11 devices →

Related Devices (Code: GQS)

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.

K093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K943557IMAGENDako Diagnostics , Ltd.K905385P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGENVirion (U.S.), Inc.K884194PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K884193PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3Microscan Div. Baxter Healthcare 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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