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FDA 510(k)

BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO

K-Number: K912838 · 1991-09-27

ApplicantBaxter Diagnostics, Inc.
Decision Date1991-09-27
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO 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 1991-09-27 under 510(k) number K912838. 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 BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO?

BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K912838.

When did BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO receive FDA 510(k) clearance?

BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO received FDA 510(k) clearance on 1991-09-27, under 510(k) number K912838.

Who is the listed applicant for BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO?

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 BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO?

The FDA product code for BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO 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.K912371BIOMERIEUX RSV DIRECT IF KITVitek Systems, 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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