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FDA 510(k)

PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT

K-Number: K884194 · 1988-11-22

ApplicantBaxter Diagnostics, Inc.
Decision Date1988-11-22
Product CodeGQS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-11-22 under 510(k) number K884194. 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 PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT?

PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT is a medical device that received FDA 510(k) clearance on 1988-11-22. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K884194.

When did PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT receive FDA 510(k) clearance?

PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT received FDA 510(k) clearance on 1988-11-22, under 510(k) number K884194.

Who is the listed applicant for PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT?

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

What is the FDA product code for PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT?

The FDA product code for PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT is GQS.

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Other records listing Baxter Diagnostics, 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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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.K884193PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1Microscan Div. Baxter Healthcare Corp.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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