Agglutinotest-Staphylolisin

FDA 510(k) K791453 · Volu Sol Medical Industries

Substantially Equivalent

510(k) numberK791453

Submission

Device name
Agglutinotest-Staphylolisin
Applicant
Volu Sol Medical Industries
Mchenry, IL, US
Received
August 6, 1979
Decision date
September 24, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GTN – Antisera, Fluorescent, All Types, Staphylococcus Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3700
Specialty
Microbiology

Other 510(k)s with product code GTN

510(k)DeviceApplicantDecision
K855236Diagnostic Reagent Tst-RplaGTN · Traditional Oxoid U.S.A., Inc.11/04/1986SE
K855233Diagnostic Reagent Set-RplaGTN · Traditional Oxoid U.S.A., Inc.11/04/1986SE
K851949Staphaurex ZL30GTN · Traditional Wellcome Diagnostics05/22/1985SE

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K812906Elvi Biclot 816KQG · Traditional 07/22/1982SE
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Questions and answers

When was Agglutinotest-Staphylolisin cleared by the FDA?

Agglutinotest-Staphylolisin (K791453) received a 510(k) decision of Substantially Equivalent on September 24, 1979, 49 days after the submission was received.

What is the product code of K791453?

The FDA product code is GTN – Antisera, Fluorescent, All Types, Staphylococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3700.