510(k) Report

510(k) · Cleared

Recalled · 2002

Resolve-CSF

K843122510(k) TraditionalCleared Nov 30, 1984114-day reviewClass I21 CFR 866.5860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Isolab, Inc. · DFI Total Spinal-Fluid, Antigen, Antiserum, Control

Cleared on Nov 30, 1984 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
Nov 30, 1984
Review
114 days
Class
Class I
Product code
DFI
Recalls
1
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K843122Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 16, 2002Not classifiedZ-0973-03OtherThe CSF Gels were manufactured incorrectly resulting in irregular wavy bands.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DFI devices

DFI Total Spinal-Fluid, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DFI

FDA has decided no DFI device since 2007.

Median 510(k) review, days · DFI

Too few DFI 510(k)s in any year since 2007 to give a median.

Recalls per year · DFI

No recall names DFI since 2007.

Adverse event reports per year · DFI

No MAUDE report names DFI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Isolab, Inc.

44 FDA decisions under this applicant name. See the company

  • K951014Isolab's T4 Test KitIsolab, Inc. · 1996
  • K950481Neonatal Chemistry System, Galactose Test KitIsolab, Inc. · 19965 recalls
  • K943547Phenylalanine Test KitIsolab, Inc. · 1996
  • K950803Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 SampleIsolab, Inc. · 19952 recalls
  • K950415Fluoroscan NeonatalIsolab, Inc. · 1995

Recent decisions in DFI

The DFI category page

  • K854190Cantrol Spinal Fluid ControlCanyon Diagnostics, Inc. · 1985
  • K840974Somas Human Spinal Fluid ControlSomas Medical Industries, Inc. · 1984
  • K832821Fiax Igg TestIntl. Diagnostic Technology · 1983

https://510kreport.com/device/K843122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K843122: Resolve-CSF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843122

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026