Actech Advanced Clinical Technologies, Inc.: FDA filings under this applicant name

FDA lists 0 510(k) clearances under the applicant name “Actech Advanced Clinical Technologies, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Top product codes

Product codeDeviceSubmissions510(k) clearances
MCLKit, Test, In Vitro Periodontal10

Review panels

PMA and De Novo decisions

NumberPathwayDeviceDecision date
P870059PMAPERIOCHECK TM ENZYME ACTIVITY TEST KIT1990-08-14

Recalls

openFDA lists no recalls under a recalling firm named Actech Advanced Clinical Technologies, Inc..

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.

Frequently asked questions

How many FDA 510(k) clearances are listed under Actech Advanced Clinical Technologies, Inc.?

FDA lists 0 510(k) clearances under the applicant name “Actech Advanced Clinical Technologies, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

Which FDA product codes appear under Actech Advanced Clinical Technologies, Inc.?

The most frequent FDA product codes under this applicant name are MCL (Kit, Test, In Vitro Periodontal, 1).

Next steps

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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