510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K800671Substantially Equivalent

Smac Replacement Reagents-Wash Solutions

Diagnostic Solutions, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800671 is the FDA 510(k) clearance record for SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS, cleared for Diagnostic Solutions, Inc. on . FDA records list 26 510(k) clearances for Diagnostic Solutions, Inc., from to . As of , FDA records show no recalls naming K800671.

Clearance record

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