510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K810003Substantially Equivalent

'No-Boil' Folic Acid Kit

Siemens Healthcare Diagnostics Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810003 is the FDA 510(k) clearance record for 'NO-BOIL' FOLIC ACID KIT, cleared for Diagnostic Products Corp. on . FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K810003.

Clearance record

Decision date
Received
(15 days to decision)
Review panel
Unknown
Applicant
Diagnostic Products Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No