510(k) Report

510(k) · Cleared

Cleared

Ria Kit, Prolactin

K790003510(k) TraditionalCleared Mar 12, 197969-day reviewClass I21 CFR 862.1625

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

Cis Radiopharmaceuticals, Inc. · CFT Radioimmunoassay, Prolactin (Lactogen)

Cleared on Mar 12, 1979 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 12, 1979
Review
69 days
Class
Class I
Product code
CFT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790003Source: 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 CFT? 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 CFT devices

CFT Radioimmunoassay, Prolactin (Lactogen): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFT

FDA has decided no CFT device since 2007.

Median 510(k) review, days · CFT

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

Recalls per year · CFT

1in 2018

2009: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CFT

23in 2025

2009: 22010: 12011: 42012: 42014: 12016: 62017: 182018: 272019: 122020: 202021: 232022: 292023: 272024: 252025: 23
2007high 29 (2022) · low 0 (2007)2025

MAUDE reports naming product code CFT, 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—12
20100—01
20110—04
20120—04
20130—00
20140—01
20150—00
20160—06
20170—018
20180—127
20190—012
20200—020
20210—023
20220—029
20230—027
20240—025
20250—023
20260—0—

More from Cis Radiopharmaceuticals, Inc.

9 FDA decisions under this applicant name. See the company

  • K791860Ferritin Ria KitCis Radiopharmaceuticals, Inc. · 1979
  • K792063Follicle Stimulating Hormone (FSH) KitCis Radiopharmaceuticals, Inc. · 1979
  • K791202Ria Kit for TrypsinCis Radiopharmaceuticals, Inc. · 19791 recall
  • K792000Luteinizing Hormone (LH) RiaCis Radiopharmaceuticals, Inc. · 1979
  • K791051Progesterone Radioimmunoassay KitCis Radiopharmaceuticals, Inc. · 1979

Recent decisions in CFT

The CFT category page

  • K971921Prolactin (PRL) Hormone Microplate ElisaMonobind · 1997
  • K970281Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsJohnson & Johnson Clinical Diagnostics, Inc. · 19972 recalls
  • K970188Sealite Sciences, Inc. Aqualite ProlactinSealite Sciences, Inc. · 1997
  • K964748Elecsys Prolactin AssayBoehringer Mannheim Corp. · 1997
  • K960561DSL Active Prolactin Elisa Model 10-4500Diagnostic Systems Laboratories, Inc. · 19961 recall

https://510kreport.com/device/K790003 · printed Nov 5, 2026

Cite this page

510(k) Report. “K790003: Ria Kit, Prolactin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K790003

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