510(k) Report

510(k) · Cleared

Cleared

Immulite (HPL) (Human Placental Plactogen)

K944933510(k) TraditionalCleared Mar 10, 1995155-day reviewClass II21 CFR 862.1585

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

Diagnostic Products Corp. · JMF Radioimmunoassay, Human Placental Lactogen

Cleared on Mar 10, 1995 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 10, 1995
Review
155 days
Class
Class II
Product code
JMF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K944933Source: 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 JMF devices

JMF Radioimmunoassay, Human Placental Lactogen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JMF

FDA has decided no JMF device since 2007.

Median 510(k) review, days · JMF

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

Recalls per year · JMF

No recall names JMF since 2007.

Adverse event reports per year · JMF

No MAUDE report names JMF 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 Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in JMF

The JMF category page

  • K840588Amerlex Human Placental LactogenAmersham Corp. · 1984
  • K823292Immophase TM HPL RadioimmunoassayCorning Medical & Scientific · 1982
  • K823201Human Placental Lactogen KitDiagnostic Products Corp. · 1982
  • K811370Natal-Tec HPLArmkel, LLC · 1981
  • K802454Geste Follow Kit Determ. of HPLSyn-Kit, Inc. · 1980

https://510kreport.com/device/K944933 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944933: Immulite (HPL) (Human Placental Plactogen).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944933

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