510(k) Report

510(k) · Cleared

Cleared

Amylase Test (Amyl) Item Number: 65653

K884382510(k) TraditionalCleared Jan 11, 198985-day reviewClass II21 CFR 862.1070

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

Em Diagnostic Systems, Inc. · CIW Starch-Dye Bound Polymer, Amylase

Cleared on Jan 11, 1989 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 11, 1989
Review
85 days
Class
Class II
Product code
CIW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K884382Source: 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 CIW devices

CIW Starch-Dye Bound Polymer, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIW

FDA has decided no CIW device since 2007.

Median 510(k) review, days · CIW

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

Recalls per year · CIW

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CIW

No MAUDE report names CIW 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—10
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 Em Diagnostic Systems, Inc.

288 FDA decisions under this applicant name. See the company

  • K935181Aspartate Aminotransferase (Ast) TestEm Diagnostic Systems, Inc. · 1994
  • K935180Alanine Aminotransferase (Alt) TestEm Diagnostic Systems, Inc. · 1994
  • K935179Emds Albumin (Alb) TestEm Diagnostic Systems, Inc. · 1993
  • K935178Emds Phosphorous (Phos) TestEm Diagnostic Systems, Inc. · 1993
  • K935175Lactate Dehydrogenase (LD)Em Diagnostic Systems, Inc. · 1993

Recent decisions in CIW

The CIW category page

  • K931559Dma Amylase ProcedureData Medical Associates, Inc. · 1993
  • K924339Olympus Amylase ReagentOlympus Corp. · 1992
  • K850639Enzymatic Alpha-Amylase Reagent KitBio-Analytics Laboratories, Inc. · 1985
  • K812027Kodak Ektachem Clin. Chem. Slides (Amyl)Eastman Kodak Company · 19815 recalls
  • K810584Phadebas Isoamylase TestPharmacia, Inc. · 1981

https://510kreport.com/device/K884382 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884382: Amylase Test (Amyl) Item Number: 65653.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884382

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