Roche Diagnostics Corp.: FDA filings under this applicant name

FDA lists 451 510(k) clearances under 4 spellings of the applicant name “Roche Diagnostics Corp.” (first 1999, latest 2026), plus 15 PMA and 3 De Novo decisions, across 151 product codes in 7 review panels. Median 510(k) review time under this name: 75 days. Since 2017 the median was 166 days, against 200 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Roche Diagnostics Corp. took a median 166 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 200 days.

Top product codes

Plus 141 more product codes.

Review panels

• Clinical Chemistry (261)
• Clinical Toxicology (72)
• Immunology (58)
• Microbiology (44)
• Hematology (30)
• General Hospital (2)
• Pathology (2)

Most recent Roche Diagnostics Corp. 510(k) clearances

441 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

240 product recalls in 107 recall events; 0 initiated in the last five years. Most recent: 2019-06-03.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Roche Diagnostics Corp. (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via MRZ)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
• G0008 — Administration of influenza virus vaccine (via PSZ)
• E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)

FDA spellings included

FDA records this applicant under 4 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Roche Diagnostics Corp. (276)
• Roche Diagnostics (186)
• Roche Diagnostics Corporation (6)
• Roche Diagnostics, Inc. (1)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Roche Diagnostic Systems, Inc. (296 510(k)s)
• Roche Molecular Systems, Inc. (52 510(k)s)
• Roche Medical Electronics, Inc. (16 510(k)s)
• Roche Diagnostics Operations (Rdo) (14 510(k)s)
• Roche Analytical Instruments, Inc. (11 510(k)s)
• Roche Diabetes Care, Inc. (10 510(k)s)
• Roche Diagnostics Operations (7 510(k)s)
• Roche Diagnostics GmbH (5 510(k)s)
• Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
• Roche (2 510(k)s)
• Roche Diabetes Care GmbH (2 510(k)s)
• Roche Professional Diagnostics (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Roche Diagnostics Corp.?

FDA lists 451 510(k) clearances under 4 spellings of the applicant name “Roche Diagnostics Corp.” (first 1999, latest 2026), plus 15 PMA and 3 De Novo decisions, across 151 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Roche Diagnostics Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Diagnostics Corp. is 75 days. Since 2017: 166 days, versus 200 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Roche Diagnostics Corp.?

The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 58); JJY (Multi-Analyte Controls, All Kinds (Assayed), 22); NBW (System, Test, Blood Glucose, Over The Counter, 19).

Next steps

• See all 451 Roche Diagnostics Corp. clearances with predicates and recalls
• Run predicate analysis for product code JJX, Roche Diagnostics Corp.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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