Hemametrics FDA Record

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

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 1 Latest Jul 23, 2002

Hemametrics has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Hemametrics" is on file.

What these totals cover: FDA records filed under the name "Hemametrics".

Latest 510(k)
Jul 23, 2002

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances1Nov 15, 2026File dated Nov 9, 2026Current
Inspections0Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

1 510(k) clearance on Jul 23, 2002.

K-NumberDeviceDate
K011741CRIT-LINE MONITOR III TQA (CLM TQA)Jul 23, 2002

Hemametrics and the FDA: common questions

Has Hemametrics received an FDA warning letter?

No FDA warning letter addressed to the name "Hemametrics" 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 Hemametrics received an FDA Form 483?

FDA has not published a Form 483 for "Hemametrics" 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.