510(k) Report

FDA applicant

Biotech, Inc.

Irvine, CA1 decision2014–20140 recalls

FDA records 1 decision for Biotech, Inc. (Irvine, CA) in 2014: 1 510(k) clearance. All are in product code MQK (Labware, Assisted Reproduction). Its devices cite 2 predicates, 0 of them its own earlier devices. No 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 Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Biotech, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQKLabware, Assisted Reproduction1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K122982CryolockBiotech, Inc. · 20143cite it

What has FDA decided for it lately?

  • K122982CryolockBiotech, Inc. · 2014

The one decision as Biotech, Inc. →

Other applicant names beginning “Biotech”

FDA records each applicant name separately; these may or may not be the same firm.

Biotech Dental, Sas 4Biotech Atlantic, Inc. 4Biotech Research Laboratories, Inc. 2Biotech One, Inc. 2Biotech Dental Smilers, Sas 1Biotech Lubricants, Ltd. 1Biotech Medical Instruments Corp. 1