510(k) Report

FDA applicant

Mid-Atlantic Diagnostics, Inc.

Marlton, NJ4 decisions2000–20101 recall

FDA records 4 decisions for Mid-Atlantic Diagnostics, Inc. (Marlton, NJ) from 2000 to 2010: 4 510(k) clearances. Most are in product codes MQH (Microtools, Assisted Reproduction (Pipettes)) and MQK (Labware, Assisted Reproduction). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Mid-Atlantic Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mid-Atlantic Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mid-Atlantic Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQHMicrotools, Assisted Reproduction (Pipettes)2decisions
  • MQKLabware, Assisted Reproduction1decision
  • MQGAccessory, Assisted Reproduction1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K993699The StripperMid-Atlantic Diagnostics, Inc. · 20002cite it

What has FDA decided for it lately?

  • K100596CryopetteMid-Atlantic Diagnostics, Inc. · 20101 recall
  • K041435The Stripper PGDMid-Atlantic Diagnostics, Inc. · 2004
  • K030525Custom Products Ivf Workstation Type WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 and WKST-24*72D Plus…Mid-Atlantic Diagnostics, Inc. · 2003
  • K993699The StripperMid-Atlantic Diagnostics, Inc. · 2000

All 4 as Mid-Atlantic Diagnostics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K100596ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456…Nov 28, 2011