510(k) Report

510(k) · Cleared

Cleared

Calcium Qvet

K943003510(k) TraditionalCleared Dec 9, 1994169-day reviewClass I21 CFR 862.1030

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

Prisma Systems · CJJ Diazo, Alt/Sgpt

Cleared on Dec 9, 1994 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 9, 1994
Review
169 days
Class
Class I
Product code
CJJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K943003Source: 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 CJJ? 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 CJJ devices

CJJ Diazo, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CJJ

FDA has decided no CJJ device since 2007.

Median 510(k) review, days · CJJ

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

Recalls per year · CJJ

No recall names CJJ since 2007.

Adverse event reports per year · CJJ

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code CJJ, 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—01
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 Prisma Systems

27 FDA decisions under this applicant name. See the company

  • K950177CK QvetPrisma Systems · 1995
  • K943027Cholesterol QvetPrisma Systems · 1995
  • K942997Alkaline Phosphatase (Alkp) QvetPrisma Systems · 1994
  • K943001Magnesium QvetPrisma Systems · 1994
  • K942964Lactate Dehydrogenase QvetPrisma Systems · 1994

Recent decisions in CJJ

The CJJ category page

  • K895128Biotrack Alt Test CartridgeBiotrack, Inc. · 1989

https://510kreport.com/device/K943003 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943003: Calcium Qvet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943003

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