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FDA 510(k)

RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY

K-Number: K922801 · 1993-01-06

ApplicantLight Diagnostics
Decision Date1993-01-06
Product CodeGNY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1993-01-06 under 510(k) number K922801. The device is classified under product code GNY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY?

RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1993-01-06. The listed applicant is Light Diagnostics. The 510(k) number is K922801.

When did RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY receive FDA 510(k) clearance?

RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY received FDA 510(k) clearance on 1993-01-06, under 510(k) number K922801.

Who is the listed applicant for RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY?

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

What is the FDA product code for RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY?

The FDA product code for RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY is GNY.

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Other records listing Light Diagnostics 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.

K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYK990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295K972975LIGHT DIAGNOSTICS RABIES DFA REAGENTK974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

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Related Devices (Code: GNY)

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.

K885310MURINE MONOCLONAL ANTI-ADENOVIRUS IGGWhittaker Bioproducts, Inc.K770807ADENOVIRUS-GROUP FA LABELLED (8-651 RF)Flow Laboratories, Inc.K770811ADENOVIRUS GROUP-FA LABELLED PRESERUMFlow Laboratories, 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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