510(k) Report

510(k) · Cleared

Cleared

Flor. Conjug. Human Fab Fragment

K770670510(k) TraditionalCleared Apr 28, 197720-day reviewClass I21 CFR 866.5520

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

Kent Laboratories, Inc. · DFK Igg (Fab Fragment Specific), Antigen, Antiserum, Control

Cleared on Apr 28, 1977 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 28, 1977
Review
20 days
Class
Class I
Product code
DFK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770670Source: 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 DFK devices

DFK Igg (Fab Fragment Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DFK

FDA has decided no DFK device since 2007.

Median 510(k) review, days · DFK

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

Recalls per year · DFK

No recall names DFK since 2007.

Adverse event reports per year · DFK

No MAUDE report names DFK 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 Kent Laboratories, Inc.

40 FDA decisions under this applicant name. See the company

  • K951966Human Prealbumin Radial Immunodiffusion KitKent Laboratories, Inc. · 1995
  • K951968Human C1Q Radial Immunodiffusion KitKent Laboratories, Inc. · 1995
  • K951967Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion KitKent Laboratories, Inc. · 1995
  • K950102Human C-5 Radial Immunodiffusion KitKent Laboratories, Inc. · 1995
  • K85068372 Determ. Size Radial Immunodiffusion Test ALPHA2Kent Laboratories, Inc. · 1985

Recent decisions in DFK

The DFK category page

  • K790711Antisera to Human FragmentKent Laboratories, Inc. · 1979
  • K771243Antisera to Human Fab FragmentKent Laboratories, Inc. · 1977

https://510kreport.com/device/K770670 · printed Nov 4, 2026

Cite this page

510(k) Report. “K770670: Flor. Conjug. Human Fab Fragment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K770670

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