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
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K852107Substantially Equivalent

Sickle-Chex

Streck Laboratories, Inc., Omaha NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852107 is the FDA 510(k) clearance record for SICKLE-CHEX, cleared for Streck Laboratories, Inc. on . FDA records list 70 510(k) clearances for Streck Laboratories, Inc., from to . As of , FDA records show no recalls naming K852107.

Clearance record

Decision date
Received
(51 days to decision)
Review panel
Unknown
Applicant
Streck Laboratories, Inc. P.O. Box 37625, Omaha NE
Third party review
No