510(k) Report

FDA product code · Microbiology

Antiserum, Cf, Psittacosis (Chlamydia Group)

GPTClass I21 CFR 866.3120510(k) required1 decision since 19810 recalls

1 FDA decision since 1981. No recall names this code.

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

FIG. A — Illustration, microbiology panel

Twenty years of GPT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · GPT

FDA has decided no GPT device since 2007.

Median 510(k) review, days · GPT

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

Recalls per year · GPT

No recall names GPT since 2007.

Adverse event reports per year · GPT

No MAUDE report names GPT 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—
FIG. 1 — GPT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GPT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in GPT lately?

  • K810856Direct Immunofluor. Antibody Test KitBartels Immunodiagnostic Supplies, Inc. · 1981

The one GPT decision →

Related product codes

Other codes under 21 CFR 866.3120.

LKI Antisera, Fluorescent, Chlamydia Spp.MKZ Dna Probe, Nucleic Acid Amplification, ChlamydiaGPW Antigen, Cf, Psittacosis (Chlamydia Group)LJC Enzyme Linked Immunoabsorbent Assay…LSK Dna-Reagents, ChlamydiaLKH Antisera, Immunoperoxidase, Chlamydia Spp.MGM C. Trachomatis (Chlamydia Group)LJP Antiserum, Fluorescent, Chlamydia Trachomatis