Resolve-Csf

FDA 510(k) K843122 · Isolab, Inc.

Substantially Equivalent

510(k) numberK843122

Submission

Device name
Resolve-Csf
Applicant
Isolab, Inc.
Akron, OH, US
Received
August 8, 1984
Decision date
November 30, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DFI – Total Spinal-Fluid, Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5860
Specialty
Immunology

Other 510(k)s with product code DFI

510(k)DeviceApplicantDecision
K854190Cantrol Spinal Fluid ControlDFI · Traditional Canyon Diagnostics, Inc.11/25/1985SE
K840974Somas Human Spinal Fluid ControlDFI · Traditional Somas Medical Industries, Inc.04/05/1984SE
K832821Fiax Igg TestDFI · Traditional Intl. Diagnostic Technology10/14/1983SE

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K943547Phenylalanine Test KitJNB · Traditional 01/26/1996SE
K950803Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional 09/21/1995SE
K950415Fluoroscan NeonatalKHO · Traditional 09/05/1995SE
K942276Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional 01/20/1995SE
K942222Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional 01/20/1995SE
K944185IsoscanJQT · Traditional 11/17/1994SE
K934013Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional 04/26/1994SE
K923153Hemocard, Hemoglobin C AssayMLL · Traditional 01/27/1994SE

Questions and answers

When was Resolve-Csf cleared by the FDA?

Resolve-Csf (K843122) received a 510(k) decision of Substantially Equivalent on November 30, 1984, 114 days after the submission was received.

What is the product code of K843122?

The FDA product code is DFI – Total Spinal-Fluid, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5860.