510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770495Substantially Equivalent

Quanti. Colori. Det. of Serum Iron

Sigma Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770495 is the FDA 510(k) clearance record for QUANTI. COLORI. DET. OF SERUM IRON, cleared for Sigma Chemical Co. on . FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K770495.

Clearance record

Decision date
Received
(86 days to decision)
Review panel
Unknown
Applicant
Sigma Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No