Ml Strategies, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Ml Strategies, Inc. has 0 FDA recalls, 0 inspections, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ml Strategies, Inc." is on file.

What these totals cover: FDA records filed under the name "Ml Strategies, Inc." and its spelling variant "Ml Strategies".

Latest 510(k)
Dec 15, 1998

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances4Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) clearances

4 510(k) clearances from Jul 19, 1995 to Dec 15, 1998.

K-NumberDeviceDate
K983401FRAMEWAVE WEBDec 15, 1998
K973363NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633Jul 2, 1998
K972271NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-AOct 28, 1997
K950354HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCYJul 19, 1995

Ml Strategies, Inc. and the FDA: common questions

Has Ml Strategies, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Ml Strategies, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Ml Strategies, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Ml Strategies, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.