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

Elkhart, IN, US

Bayer Corp. appears in FDA device records in Elkhart, IN. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for Bayer Corp. between 1989 and 2003. The busiest year on record is 1997, with 6. The most recent is 2003, with 2.

Clearances by year, as a table
510(k) clearance decisions for Bayer Corp., by decision year
YearClearances
19891
19963
19976
19981
19995
20011
20021
20032
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K024062ASCENSIA BREEZE BLOOD GLUCOSE METERCGASubstantially Equivalent
K024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALNBWSubstantially Equivalent
K023584ASCENSIA DEX 2 DIABETES CARE SYSTEMNBWSubstantially Equivalent
K012205GLUCOMETER DEX TEST SENSORNBWSubstantially Equivalent
K992257NEW MULTIPLES REAGENT STRIPSJIRSubstantially Equivalent
K991315MICROALBUSTIX REAGENT STRIPS (OTC)JIRSubstantially Equivalent
K990649GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMSCGASubstantially Equivalent
K991242GLUCOMETER ELITE TEST STRIPSCGASubstantially Equivalent
K984006GLUCOMETER ELITE XL BLOOD GLUCOSE METERCGASubstantially Equivalent
K982219MICROALBUSTIX REAGENT STRIPSJIRSubstantially Equivalent
K972706CLINITEK MICROALBUMIN REAGENT STRIPSCJGSubstantially Equivalent
K971276GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METERCFRSubstantially Equivalent
K971209CLINITEK HCG TEST STRIPSJHISubstantially Equivalent
K964630GLUCOMETER ELITE BLOOD GLUCOSE METERCGASubstantially Equivalent
K964004GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPSCFRSubstantially Equivalent
K963500GLUCOMETER DEX DIABETES CARE SYSTEMCGASubstantially Equivalent
K963142DCA 2000 + MICROALBUMIN/CREATININE ASSAYJIRSubstantially Equivalent
K960888CHEK-STIX U.T.I. SELF-TESTJMTSubstantially Equivalent
K960546CLINITEK 50 URINE CHEMISTRY ANALYZERKQOSubstantially Equivalent
K893117GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST STCGASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

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Is this your company?

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Claiming lets Bayer Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

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