510(k) Report

510(k) · Cleared

Cleared

Follicle Stimulating Hormone Kit

K820358510(k) TraditionalCleared Mar 26, 198245-day reviewClass I21 CFR 862.1300

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

Pcl-Ria, Inc. · CGJ Radioimmunoassay, Follicle-Stimulating Hormone

Cleared on Mar 26, 1982 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 26, 1982
Review
45 days
Class
Class I
Product code
CGJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K820358Source: 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CGJ devices

CGJ Radioimmunoassay, Follicle-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGJ

FDA has decided no CGJ device since 2007.

Median 510(k) review, days · CGJ

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

Recalls per year · CGJ

1in 2023

2012: 12016: 12018: 12021: 12023: 1
2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CGJ

4in 2025

2011: 12013: 12016: 12017: 22018: 12019: 12020: 32021: 22022: 12023: 32024: 32025: 4
2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code CGJ, 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—01
20120—10
20130—01
20140—00
20150—00
20160—11
20170—02
20180—11
20190—01
20200—03
20210—12
20220—01
20230—13
20240—03
20250—04
20260—0—

More from Pcl-Ria, Inc.

29 FDA decisions under this applicant name. See the company

  • K830526B-GCG System by RiaPcl-Ria, Inc. · 1983
  • K822935Thyroid Stimulating HormonePcl-Ria, Inc. · 1982
  • K823014Digoxin KitPcl-Ria, Inc. · 1982
  • K822612T3 Uptake KitsPcl-Ria, Inc. · 1982
  • K820886Thyroxine T4 KitPcl-Ria, Inc. · 1982

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https://510kreport.com/device/K820358 · printed Nov 4, 2026

Cite this page

510(k) Report. “K820358: Follicle Stimulating Hormone Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K820358

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