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FDA 510(k)

RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT

K-Number: K852185 · 1985-08-19

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1985-08-19
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1985-08-19 under 510(k) number K852185. 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 RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT?

RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT is a medical device that received FDA 510(k) clearance on 1985-08-19. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K852185.

When did RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT receive FDA 510(k) clearance?

RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT received FDA 510(k) clearance on 1985-08-19, under 510(k) number K852185.

Who is the listed applicant for RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT?

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

What is the FDA product code for RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT?

The FDA product code for RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT is LKT.

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Other records listing Bartels Immunodiagnostic Supplies, 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.

K864776A549 (HUMAN LUNG CARCINOMA) CULTURE CELLSK861172ROTAVIRUS LATEX AGGLUTINATION ASSAYK860279CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KITK855034AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTK842830IMMUNOPER-OXIDASE TEST KIT FOR DETECT OFK844105FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY

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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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