510(k) Report

510(k) · Cleared

Cleared

Chlamydiae Fluor. AB Test for Detection in Smears

K864662510(k) TraditionalCleared Mar 25, 1987117-day reviewClass I21 CFR 866.3120

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

American Micro Scan · LJP Antiserum, Fluorescent, Chlamydia Trachomatis

Cleared on Mar 25, 1987 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 25, 1987
Review
117 days
Class
Class I
Product code
LJP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K864662Source: 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 LJP? 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 LJP devices

LJP Antiserum, Fluorescent, Chlamydia Trachomatis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJP

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJP

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

Recalls per year · LJP

No recall names LJP since 2007.

Adverse event reports per year · LJP

No MAUDE report names LJP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—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 American Micro Scan

36 FDA decisions under this applicant name. See the company

  • K870029Immunoscan (TM) Direct Streptococcus PneumoniaeAmerican Micro Scan · 1987
  • K863776Microdilution Mic PanelsAmerican Micro Scan · 1987
  • K864674Microdilution Identification PanelsAmerican Micro Scan · 1987
  • K864389Chlamydiae Flourescent Monoclonal Antibody TestAmerican Micro Scan · 1986
  • K863038Gram Positive Fluorescent Identification PanelAmerican Micro Scan · 1986

Recent decisions in LJP

The LJP category page

  • K063675Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation KitDiagnostic Hybrids, Inc. · 2007
  • K941714Chlamydia Trachomatis Antigen TestNeogenex · 1994
  • K901243Chlamydia-Cel Immunofluorenscence (IF) TestCel Labs Pty, Ltd. · 1990
  • K900870Pathodx Chlamydia Trachomatis Direct Specimen TestDiagnostic Products Corp. · 1990
  • K895839Pathodx Chlamydia Culture Confirmation PKCC1Diagnostic Products Corp. · 1990

https://510kreport.com/device/K864662 · printed Nov 5, 2026

Cite this page

510(k) Report. “K864662: Chlamydiae Fluor. AB Test for Detection in Smears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864662

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