510(k) Report

510(k) · Cleared

Cleared

Deter. of Phosphohexose Isomerase

K770577510(k) TraditionalCleared Jun 17, 197781-day reviewClass I21 CFR 862.1570

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

Sigma Chemical Co. · KLJ Nad Reduction (U.V.), Phosphohexose Isomerase

Cleared on Jun 17, 1977 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 17, 1977
Review
81 days
Class
Class I
Product code
KLJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770577Source: 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 KLJ? 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 KLJ devices

KLJ Nad Reduction (U.V.), Phosphohexose Isomerase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLJ

FDA has decided no KLJ device since 2007.

Median 510(k) review, days · KLJ

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

Recalls per year · KLJ

No recall names KLJ since 2007.

Adverse event reports per year · KLJ

No MAUDE report names KLJ 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 Sigma Chemical Co.

231 FDA decisions under this applicant name. See the company

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  • K933691Sigma CO2 Alkaline Buffer ReagentSigma Chemical Co. · 1993
  • K933679Sigma Bun ReagentSigma Chemical Co. · 1993

https://510kreport.com/device/K770577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K770577: Deter. of Phosphohexose Isomerase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770577

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