510(k) Report

510(k) · Cleared

Cleared

Seralyzer Ast/Sgot Reagent Strips

K832790510(k) TraditionalCleared Oct 14, 198359-day reviewClass II21 CFR 862.1100

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

Miles Laboratories, Inc. · CIF Vanillin Pyruvate, Ast/Sgot

Cleared on Oct 14, 1983 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 14, 1983
Review
59 days
Class
Class II
Product code
CIF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K832790Source: 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 CIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 CIF devices

CIF Vanillin Pyruvate, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIF

FDA has decided no CIF device since 2007.

Median 510(k) review, days · CIF

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

Recalls per year · CIF

No recall names CIF since 2007.

Adverse event reports per year · CIF

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code CIF, 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—01
20090—00
20100—00
20110—01
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 Miles Laboratories, Inc.

160 FDA decisions under this applicant name. See the company

  • K880605Labeling Change for Cutter Pureflo Plus IV FilterMiles Laboratories, Inc. · 1988
  • K874909Micro-Bumintest Reagent TabletsMiles Laboratories, Inc. · 1988
  • K875079Modified Seralyzer Alt/SGPT Reag. Strips & ModuleMiles Laboratories, Inc. · 1988
  • K871835Glucometer QC Blood Meter, Ames Gluco System PrintMiles Laboratories, Inc. · 1987
  • K872120Seralyzer Iii Blood Chemistry AnalyzerMiles Laboratories, Inc. · 1987

https://510kreport.com/device/K832790 · printed Nov 5, 2026

Cite this page

510(k) Report. “K832790: Seralyzer Ast/Sgot Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K832790

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