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

Cambridge, MA, US

Amnisure International, LLC appears in FDA device records in Cambridge, MA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Amnisure International, LLC in 2009.

Clearances by year, as a table
510(k) clearance decisions for Amnisure International, LLC, by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K081767AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1NQMSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0120-2008AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain