510(k) Report

510(k) · Cleared

Cleared

RPR Liquid Controls

K955143510(k) TraditionalCleared Jul 30, 1996260-day reviewClass II21 CFR 866.3820

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

Remel, L.P. · GMP Antisera, Control For Nontreponemal Tests

Cleared on Jul 30, 1996 after a 260-day review. The FDA summary names no predicate by number.

Decided
Jul 30, 1996
Review
260 days
Class
Class II
Product code
GMP
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K955143Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GMP? 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?

The FDA summary names no predicate by number.

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 GMP devices

GMP Antisera, Control For Nontreponemal Tests: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GMP

FDA has decided no GMP device since 2007.

Median 510(k) review, days · GMP

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

Recalls per year · GMP

No recall names GMP since 2007.

Adverse event reports per year · GMP

No MAUDE report names GMP 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 Remel, L.P.

10 FDA decisions under this applicant name. See the company

  • K972359Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 19971 recall
  • K964315Remel Staph Latex KitRemel, L.P. · 1997
  • K964421Remel Meropenem 10UG Susceptibility DiskRemel, L.P. · 1996
  • K96104610B Arginine BrothRemel, L.P. · 1996
  • K955136RPR Card Test KitRemel, L.P. · 1996

Recent decisions in GMP

The GMP category page

  • K980638Adi Syphilis RPR Liquid ControlsAmpcor Diagnostics, Inc. · 1998
  • K961998Qualitrol Syphsero Control SetConsolidated Technologies, Inc. · 1996
  • K885298Visuwell Reagin Test 960 Test KitAllelix Diagnostics, Inc. · 1989
  • K875180V-Trend RPRL Card TestTexas Immunology, Inc. · 1988
  • K851504VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985

https://510kreport.com/device/K955143 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955143: RPR Liquid Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955143

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026