Staphaurex ZL30

FDA 510(k) K851949 · Wellcome Diagnostics

Substantially Equivalent

510(k) numberK851949

Submission

Device name
Staphaurex ZL30
Applicant
Wellcome Diagnostics
Research Triangle Pk, NC, US
Received
May 3, 1985
Decision date
May 22, 1985
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

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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
K791453Agglutinotest-StaphylolisinGTN · Traditional Volu Sol Medical Industries09/24/1979SE

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Questions and answers

When was Staphaurex ZL30 cleared by the FDA?

Staphaurex ZL30 (K851949) received a 510(k) decision of Substantially Equivalent on May 22, 1985, 19 days after the submission was received.

What is the product code of K851949?

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