510(k) Report

510(k) · Cleared

Cleared

Ultra-Violet Glucose Reagent

K851514510(k) TraditionalCleared May 20, 198535-day reviewClass I21 CFR 862.1495

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

Bio-Analytics Laboratories, Inc. · CFA Electrode, Ion Specific, Magnesium

Cleared on May 20, 1985 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 20, 1985
Review
35 days
Class
Class I
Product code
CFA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K851514Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in CFA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CFA devices

CFA Electrode, Ion Specific, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFA

FDA has decided no CFA device since 2007.

Median 510(k) review, days · CFA

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

Recalls per year · CFA

No recall names CFA since 2007.

Adverse event reports per year · CFA

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code CFA, not matched to any one device; reports are not rates.

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—01
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 Bio-Analytics Laboratories, Inc.

19 FDA decisions under this applicant name. See the company

  • K861638Kinetic Alkaline Phosphatase Reagent KitBio-Analytics Laboratories, Inc. · 1986
  • K860245Enzymatic Alpha-Amylase Reagent KitBio-Analytics Laboratories, Inc. · 1986
  • K860213Albumin Reagent KitBio-Analytics Laboratories, Inc. · 1986
  • K851513Ultra-Violet Bun Reagent KitBio-Analytics Laboratories, Inc. · 1985
  • K850639Enzymatic Alpha-Amylase Reagent KitBio-Analytics Laboratories, Inc. · 1985

Recent decisions in CFA

The CFA category page

  • K863267Magnesium ProcedureData Medical Associates, Inc. · 1986

https://510kreport.com/device/K851514 · printed Nov 5, 2026

Cite this page

510(k) Report. “K851514: Ultra-Violet Glucose Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851514

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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