510(k) Report

510(k) · Cleared

Cleared

Gamma Fetal Bleed Screening Test

K820647510(k) TraditionalCleared May 12, 198264-day reviewClass II21 CFR 864.7455

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

Gamma Biologicals, Inc. · LIM Test, Screening, For D Positive Fetal Rbc'S

Cleared on May 12, 1982 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 12, 1982
Review
64 days
Class
Class II
Product code
LIM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K820647Source: 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 LIM devices

LIM Test, Screening, For D Positive Fetal Rbc'S: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIM

FDA has decided no LIM device since 2007.

Median 510(k) review, days · LIM

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

Recalls per year · LIM

No recall names LIM since 2007.

Adverse event reports per year · LIM

1in 2024

2014: 12024: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code LIM, 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—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

More from Gamma Biologicals, Inc.

21 FDA decisions under this applicant name. See the company

  • K864207Disposable Test Cards/Gamma Slide Test Infect MonoGamma Biologicals, Inc. · 1986
  • K861016Gamma Slide Test for Infectious MononucleosisGamma Biologicals, Inc. · 1986
  • K832473Gamma Slide Test for PregnancyGamma Biologicals, Inc. · 1983
  • K813342Gamma Chloroquine Diphosphate SolutionGamma Biologicals, Inc. · 1982
  • K820072FE-Cult PlusGamma Biologicals, Inc. · 1982

Recent decisions in LIM

The LIM category page

  • K980314Fetal D Tection KitBiopool Intl., Inc. · 1998

https://510kreport.com/device/K820647 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820647: Gamma Fetal Bleed Screening Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820647

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