D.R.G. Scientific Industries: FDA filings under this applicant name

FDA lists 5 510(k) clearances under the applicant name “D.R.G. Scientific Industries” (first 1986, latest 1989), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 55 days. 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

YearClearancesMedian review days
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Top product codes

Product codeDeviceSubmissions510(k) clearances
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph11
FKHSolution-Test Standard-Conductivity, Dialysis11
FKQSystem, Dialysate Delivery, Central Multiple Patient11
JITCalibrator, Secondary11
JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide11

Review panels

Most recent D.R.G. Scientific Industries 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K892329OSMOMETER STANDARD SOLUTIONSJIT1989-10-31209
K870889ACID FUCHSIN SOLUTIONSFKQ1987-07-08125
K863880BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.CHL1986-11-2449
K863825CO-OXIMETER SOLUTIONSJKS1986-11-2455
K863824SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.FKH1986-10-2424

Recalls

openFDA lists no recalls under a recalling firm named D.R.G. Scientific Industries.

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 D.R.G. Scientific Industries?

FDA lists 5 510(k) clearances under the applicant name “D.R.G. Scientific Industries” (first 1986, latest 1989), across 5 product codes in 3 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 D.R.G. Scientific Industries?

The median time from FDA receipt to decision across 510(k)s cleared under the name D.R.G. Scientific Industries is 55 days.

Which FDA product codes appear under D.R.G. Scientific Industries?

The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 1); FKH (Solution-Test Standard-Conductivity, Dialysis, 1); FKQ (System, Dialysate Delivery, Central Multiple Patient, 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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