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

HUNTINGDON, Cambridgeshire, GB

CAMBRIDGE SENSORS LIMITED appears in FDA device records in HUNTINGDON, Cambridgeshire, GB. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Cambridge Sensors Limited between 2007 and 2012. The busiest year on record is 2007, with 1. The most recent is 2012, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cambridge Sensors Limited, by decision year
YearClearances
20071
20091
20121
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K102383MICRODOT & MICRODOT XTRANBWSubstantially Equivalent
K083273MICRODOT XTRANBWSubstantially Equivalent
K070524MICRODOT BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially Equivalent

Registered establishments

FDA registered establishments for Cambridge Sensors Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30041761683004176168CAMBRIDGE SENSORS LIMITEDUNITS 9&10 CARDINAL PARK, HUNTINGDON, Cambridgeshire PE29 2XG GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2357-2019Microdot Xtra blood glucose test stripsThe firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly "notch" BG test strips intended for use in the US. The impacted strips did not fit into the inlet port of the BG meter, therefore resulting in a delay in BG testing and results.Class IIOpen, Classified

Verification record

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