510(k) Report

510(k) · Cleared

Cleared

Synchron CX Systems (Lap) Reagent Kit

K895850510(k) TraditionalCleared Dec 5, 198963-day reviewClass I21 CFR 862.1460

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

Beckman Instruments, Inc. · JGG L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

Cleared on Dec 5, 1989 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 5, 1989
Review
63 days
Class
Class I
Product code
JGG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K895850Source: 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.

Planning a device in JGG? 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
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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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JGG devices

JGG L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGG

FDA has decided no JGG device since 2007.

Median 510(k) review, days · JGG

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

Recalls per year · JGG

No recall names JGG since 2007.

Adverse event reports per year · JGG

No MAUDE report names JGG 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 Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in JGG

The JGG category page

  • K844965Leucine Aminopeptidase ReagentAlladin Diagnostic, Inc. · 1985

https://510kreport.com/device/K895850 · printed Nov 6, 2026

Cite this page

510(k) Report. “K895850: Synchron CX Systems (Lap) Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895850

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