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

Napa, CA, US

Alamar Biosciences Laboratory, Inc. appears in FDA device records in Napa, CA. FDA records list 26 510(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
26
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 26 510(k) clearances for Alamar Biosciences Laboratory, Inc. between 1989 and 1994. The busiest year on record is 1991, with 13. The most recent is 1994, with 2.

Clearances by year, as a table
510(k) clearance decisions for Alamar Biosciences Laboratory, Inc., by decision year
YearClearances
19891
19902
199113
19924
19934
19942
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K941425ALAMAR ANTIBIOTIC SUSCEPTIBILITYLRGSubstantially Equivalent
K926248READERLRHSubstantially Equivalent
K926002ALAMAR BACTERIAL IDENTIFICATION TEST PANELJSSSubstantially Equivalent
K925951READARLRGSubstantially Equivalent
K930469ANTIMICROBIAL SUSCEPTIBILITY TEST PANELJWYSubstantially Equivalent
K930055ANTIMICROBIAL SUSCEPTIBILITY TEST PANELJWYSubstantially Equivalent
K924500ANTIMICROBIAL SUSCEPTIBILITY TESTJWYSubstantially Equivalent
K922780ANTIMICROBIAL SUSCEPTIBILITY TEST PANELJWYSubstantially Equivalent
K922003ANTIMICROBIAL SUSCETIBILITY TEST PANELJWYSubstantially Equivalent
K922168ANTIMICROBIAL SUSCEPTIBILITY TEST PANELJWYSubstantially Equivalent
K911558ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOINJWYSubstantially Equivalent
K911559ANTIMICROBIAL SUSCEPT. TEST PANEL CEFONICIDJWYSubstantially Equivalent
K911557ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLINJWYSubstantially Equivalent
K911556ANTIMICROBIAL SUSCEPT. TEST PANEL TICARC./CLAVUL.JWYSubstantially Equivalent
K911555ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL.JWYSubstantially Equivalent
K911305ANTIMICROBIAL GENTAMICINJWYSubstantially Equivalent
K911304ANTIMICROBIAL TOBRAMYCINJWYSubstantially Equivalent
K911185ANTIMICROBIAL AMPICILLINJWYSubstantially Equivalent
K911303ANTIMICROBIAL AMIKACINJWYSubstantially Equivalent
K911187ANTIMICROBIAL CEFUROXIMEJWYSubstantially Equivalent
K911186ANTIMICROBIAL AMPICILLIN/SULBACTAMJWYSubstantially Equivalent
K905853ANTIMICROBIAL SUSCEPTIBILITY TEST PANELJWYSubstantially Equivalent
K904689ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICSJWYSubstantially Equivalent
K904523ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIEDJWYSubstantially Equivalent
K896965ANTIMICROBIAL SUSCEPTIBILITY TEST PANELJWYSubstantially Equivalent
K894514ANTIMICROBIAL SUSCEPTIBILITY TEST PANELJWYSubstantially 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

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