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

San Jose, CA, US

Behring Diagnostics, Inc. appears in FDA device records in San Jose, CA. FDA records list 145 510(k) clearances between and , one PMA record and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
145
PMA records
1
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 145

FDA records hold 145 510(k) clearances for Behring Diagnostics, Inc. between 1976 and 1997. The busiest year on record is 1996, with 25. The most recent is 1997, with 15.

Clearances by year, as a table
510(k) clearance decisions for Behring Diagnostics, Inc., by decision year
YearClearances
19763
19771
19845
198511
19868
19876
19886
19896
19909
19913
199215
199310
19949
199513
199625
199715
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K973832OPUS HLH CONTROLSJJXSubstantially Equivalent
K972929N ANTISERUM TO HUMAN ALBUMINDCFSubstantially Equivalent
K972840N ANTISERUM TO HUMAN TRANSFERRINDDGSubstantially Equivalent
K973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMDBFSubstantially Equivalent
K972316OPUS D-DIMERGHHSubstantially Equivalent
K972116VON WILLEBRAND REAGENTGGPSubstantially Equivalent
K972011OPUS ETHANOLDICSubstantially Equivalent
K971600EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)DKBSubstantially Equivalent
K971596EMIT II OPIATES 300/2000 ASSAYDJGSubstantially Equivalent
K964595OPUS PSA TEST SYSTEMLTJSubstantially Equivalent
K971725OPUS PROGESTERONEJLSSubstantially Equivalent
K970645BC THROMBIN REAGENTGJASubstantially Equivalent
K970431BEHRING COAGULATION SYSTEMJPASubstantially Equivalent
K964764OPUS BONE ALPCINSubstantially Equivalent
K964527N RHEUMATOLOGY STANDARD SLJIXSubstantially Equivalent
K964687N LATEX CRP MONO REAGENTDCHSubstantially Equivalent
K962968PROC APC ASSAY, PROC CONTROL PLASMAGGPSubstantially Equivalent
K964062N PROTEIN STRANDARD SLJIXSubstantially Equivalent
K964065N/T PROTEIN CONTROL SLJJYSubstantially Equivalent
K963084OPUS CMV TEST SYSTEM-MODIFICATIONLFZSubstantially Equivalent
K955596N LATEX B2-MICROGLOBULIN REAGENTJZGSubstantially Equivalent
K962519EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORSLCDSubstantially Equivalent
K962866OPUS HLHCEPSubstantially Equivalent
K962841OPUS MYOGLOBIN CONTROLSJJXSubstantially Equivalent
K960257N ANTISERUM TO C1 INHIBITORDBASubstantially Equivalent
K962407N/T PROTEIN CONTROL PYGILSubstantially Equivalent
K962694OPUS B12 CONTROLSJJXSubstantially Equivalent
K962410N PROTEIN STANDARD PYJIXSubstantially Equivalent
K962406N CRP STANDARD SYJIXSubstantially Equivalent
K962373N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2DCKSubstantially Equivalent
K962523N LATEX CRP MONO REAGENTDCKSubstantially Equivalent
K955278BEHRING COAGULATION TIMERGGNSubstantially Equivalent
K960275OPUS CK-MB & TOTAL CK CONTROLSJJTSubstantially Equivalent
K961206OPUS T3 CONTROLSJJXSubstantially Equivalent
K955450PATHROMTIN SLGFOSubstantially Equivalent
K955468OPUS PROLACTIN CONTROLSJJXSubstantially Equivalent
K955448EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLSDLBSubstantially Equivalent
K955858N/T PROTEIN CONTROL SY/L, M AND HJJYSubstantially Equivalent
K955857N PROTEIN STANDARS SYCZWSubstantially Equivalent
K955284OPUS TROPONIN IMMISubstantially Equivalent
K954291OPUS TDM CONTROLSDIFSubstantially Equivalent
K954144OPUS HCG CONTROLSJJXSubstantially Equivalent
K953160OPUS T3CDPSubstantially Equivalent
K953097OPUS T4 CONTROLSJJXSubstantially Equivalent
K953455OPUS B12CDDSubstantially Equivalent
K952594N PROTEIN STANDARD SYCZWSubstantially Equivalent
K952593N/T PROTEIN CONTROL SY/L, M AND HDADSubstantially Equivalent
K951434OPUS PROCAINAMIDELARSubstantially Equivalent
K952309N LATEX IGACZPSubstantially Equivalent
K926551BEHRING FIBRINTIMER AJPASubstantially 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