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FDA 510(k)

ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST

K-Number: K882687 · 1988-08-30

ApplicantGull Laboratories, Inc.
Decision Date1988-08-30
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1988-08-30 under 510(k) number K882687. 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 ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST?

ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K882687.

When did ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST receive FDA 510(k) clearance?

ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST received FDA 510(k) clearance on 1988-08-30, under 510(k) number K882687.

Who is the listed applicant for ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST?

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

What is the FDA product code for ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST?

The FDA product code for ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST is LKT.

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Other records listing Gull Laboratories, 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.

K983541HSV 1+2 IGG ELISA TESTK971857MUMPS IGG ELISA TESTYK962343TOXO IGG ELISA TESTK935730EBNA IGG ELISA TESTK940093EBV-EA(D) IGG ELISA TESTK941046VZV IGG ELISA TEST

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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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