510(k) Report

FDA applicant

Blackhawk Biosystems, Inc.

San Ramon, CA4 decisions1994–19980 recalls

FDA records 4 decisions for Blackhawk Biosystems, Inc. (San Ramon, CA) from 1994 to 1998: 4 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and MJZ (Kit, Direct Antigen, Positive Control). 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, clinical chemistry panel, where it files most

How often FDA has decided Blackhawk Biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blackhawk Biosystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)3decisions
  • MJZKit, Direct Antigen, Positive Control1decision

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.

  • K974613Virotrol IiiBlackhawk Biosystems, Inc. · 19982cite it
  • K942295Virotrol TorchBlackhawk Biosystems, Inc. · 19941cites it

What has FDA decided for it lately?

  • K974613Virotrol IiiBlackhawk Biosystems, Inc. · 1998
  • K972129Chlamydiatrol AGBlackhawk Biosystems, Inc. · 1997
  • K954298Virotrol IVBlackhawk Biosystems, Inc. · 1995
  • K942295Virotrol TorchBlackhawk Biosystems, Inc. · 1994

All 4 as Blackhawk Biosystems, Inc. →