Data / FDA device clearances / Clinical Chemistry

FDA Clinical Chemistry device clearances: 176 since Nov 2024

The full list. FDA clinical chemistry device clearances and approvals: 176 rows for $8.80, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 8 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/clinical-chemistry, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 176 device decisions in clinical chemistry (FDA review panel) from November 19, 2024 to October 30, 2026: 122 510(k) clearances and De Novo grants and 54 PMA approvals and supplements, for 69 applicants. The newest, K260738 on October 30, 2026, is Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System from Changsha Sinocare, Inc..

The request: Every new FDA clearance or approval of a clinical chemistry device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

• 176Decisions
• 122510(k) and De Novo
• 54PMA
• October 30, 2026Latest decision

Newest decisions

The newest 100 of 176, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Applicants with the most decisions

By decision type

By state or country

Where FDA publishes these decisions

• FDA 510(k) database
• FDA PMA database
• openFDA device API

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.