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FDA 510(k)

RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION

K-Number: K884192 · 1988-11-22

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

Device Summary

RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION 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 K884192. The device is classified under product code LKT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION?

RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION 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 K884192.

When did RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION receive FDA 510(k) clearance?

RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION received FDA 510(k) clearance on 1988-11-22, under 510(k) number K884192.

Who is the listed applicant for RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION?

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 RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION?

The FDA product code for RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION is LKT.

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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: LKT)

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.

K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.K942173RSV ANTIGEN TESTNeogenexK912842RSV-MAB TESTGull Laboratories, Inc.K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter Diagnostics, 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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