SEKISUI Diagnostics, LLC: FDA filings under this applicant name

FDA lists 6 510(k) clearances under the applicant name “SEKISUI Diagnostics, LLC” (first 2012, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 167 days. Since 2017 the median was 167 days, against 138 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.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name SEKISUI Diagnostics, LLC took a median 167 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.

Top product codes

Review panels

• Microbiology (5)
• Hematology (1)

Most recent SEKISUI Diagnostics, LLC 510(k) clearances

Recalls

4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2013-09-16.

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.

Device clinical trials

An industry sponsor named SEKISUI Diagnostics, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT01753531: Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B (Completed, started 2012-11)

Related HCPCS codes

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

• G0008 — Administration of influenza virus vaccine (via GNX)

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.

• Sekisui Diagnostics P.E.I., Inc. (6 510(k)s)
• Sekisui Medical Co., Ltd. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under SEKISUI Diagnostics, LLC?

FDA lists 6 510(k) clearances under the applicant name “SEKISUI Diagnostics, LLC” (first 2012, latest 2025), across 4 product codes in 2 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 SEKISUI Diagnostics, LLC?

The median time from FDA receipt to decision across 510(k)s cleared under the name SEKISUI Diagnostics, LLC is 167 days. Since 2017: 167 days, versus 138 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under SEKISUI Diagnostics, LLC?

The most frequent FDA product codes under this applicant name are PSZ (Devices Detecting Influenza A, B, And C Virus Antigens, 3); GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, 1); KHE (Reagent, Occult Blood, 1).

Next steps

• See all 6 SEKISUI Diagnostics, LLC clearances with predicates and recalls
• Run predicate analysis for product code PSZ, SEKISUI Diagnostics, LLC'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, with punctuation and legal suffixes removed; 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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