510(k) Report

510(k) · Cleared

Cleared

QM300 ALPHA1-Acid Glycoprotein Antibody Pack

K894538510(k) TraditionalCleared Aug 4, 198915-day reviewClass I21 CFR 866.5530

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

Kallestad Diag, A Div. of Erbamont, Inc. · DBN Fc, Antigen, Antiserum, Control

Cleared on Aug 4, 1989 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 4, 1989
Review
15 days
Class
Class I
Product code
DBN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K894538Source: 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 DBN devices

DBN Fc, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DBN

FDA has decided no DBN device since 2007.

Median 510(k) review, days · DBN

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

Recalls per year · DBN

No recall names DBN since 2007.

Adverse event reports per year · DBN

No MAUDE report names DBN 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 Kallestad Diag, A Div. of Erbamont, Inc.

58 FDA decisions under this applicant name. See the company

  • K910885QM300 Calibrator G PackKallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K910886QM300 Antistreptolysin O (Aso) Antigen PackKallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K910887QM300 Control G PackKallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K904725Chlamydia System Software (CSS)Kallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K902253Pathfinder (TM) Chlamydia Microplate KitKallestad Diag, A Div. of Erbamont, Inc. · 1990

https://510kreport.com/device/K894538 · printed Nov 5, 2026

Cite this page

510(k) Report. “K894538: QM300 ALPHA1-Acid Glycoprotein Antibody Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894538

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