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
K840105Unknown

Apo a-I Ria Kit-Human Plasma Apolip-

Iso-Tex Diagnostics, Mchenry IL / Traditional, Unknown
FDA source (opens on fda.gov)

K840105 is the FDA 510(k) clearance record for APO A-I RIA KIT-HUMAN PLASMA APOLIP-, cleared for Iso-Tex Diagnostics on . FDA records list 3 510(k) clearances for Iso-Tex Diagnostics, from to . As of , FDA records show no recalls naming K840105.

Clearance record

Decision date
Received
(0 days to decision)
Review panel
Unknown
Applicant
Iso-Tex Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No