510(k) Report

510(k) · Cleared

Cleared

Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)

K951494510(k) TraditionalCleared Dec 11, 1995255-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

Emd Chemicals, Inc. · CIJ Saccharogenic, Amylase

Cleared on Dec 11, 1995 after a 255-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 11, 1995
Review
255 days
Class
Class II
Product code
CIJ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K951494Source: 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 lists a 510(k) statement for it but has not posted the file, 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 CIJ devices

CIJ Saccharogenic, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIJ

FDA has decided no CIJ device since 2007.

Median 510(k) review, days · CIJ

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

Recalls per year · CIJ

No recall names CIJ since 2007.

Adverse event reports per year · CIJ

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code CIJ, 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—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Emd Chemicals, Inc.

62 FDA decisions under this applicant name. See the company

  • K031367Duopath Verotoxins Glisa TestEmd Chemicals, Inc. · 2004
  • K990516Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 19993 recalls
  • K981926Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 1998
  • K973054Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 1997
  • K951750Glucose Test Item Number 97375/94Emd Chemicals, Inc. · 1995

Recent decisions in CIJ

The CIJ category page

  • K023396Amylase Eps-G7 (Liquid) Reagent Set, (Hitachi Analyzers)Pointe Scientific, Inc., · 2002
  • K991817Additional Ims Assays for the Bayer Advia Ims SystemBayer Corp. · 1999
  • K980013AmylaseAc Biochemicals, Inc. · 1998
  • K953211Amylase (Ethylidene PNGPG7) KitRandox Laboratories, Ltd. · 19961 recall
  • K940735Liquid Amylase (CNPG3) Reagent SetPointe Scientific, Inc., · 1994

https://510kreport.com/device/K951494 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951494: Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951494

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