FDA 510(k) Applications for Medical Device:
Kappa, Antigen, Antiserum, Control

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K822671 AMICO LAB, INC.
K822668 AMICO LAB, INC.
K822669 AMICO LAB, INC.
K822670 AMICO LAB, INC.
K822666 AMICO LAB, INC.
K822667 AMICO LAB, INC.
K822679 AMICO LAB, INC.
K822678 AMICO LAB, INC.
K822675 AMICO LAB, INC.
K822676 AMICO LAB, INC.
K822677 AMICO LAB, INC.
K822673 AMICO LAB, INC.
K822674 AMICO LAB, INC.
K823121 AMICO LAB, INC.
K842326 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.
K884276 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337
BREA CA 92622 8000
K902484 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337
BREA CA 92622 8000
K884597 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337
BREA CA 92622 8000
K964260 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337
BREA CA 92622-8000
K880341 BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY
SOMERVILLE NJ 08876
K950150 BIOTEK SOLUTIONS, INC. 120-B CREMONA DR.
SANTA BARBARA CA 93117
K950152 BIOTEK SOLUTIONS, INC. 120-B CREMONA DR.
SANTA BARBARA CA 93117
K812485 DAKO CORP.
K812661 DAKO CORP.
K791284 DIAGNOSTICA, INC.
K153394 Diazyme Laboratories 12889 Gregg Court
Poway CA 92064
K181438 Diazyme Laboratories Inc. 12889 Gregg Court
Poway CA 92130
K832266 GELCO DIAGNOSTICS, INC.
K832256 GELCO DIAGNOSTICS, INC.
K781028 ICL SCIENTIFIC
K781027 ICL SCIENTIFIC
K811721 IMMULOK, INC.
K875164 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR.
CHASKA MN 55318
K802283 KALLESTAD LABORATORIES, INC.
K855008 KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR.
CHASKA MN 55318
K790706 KENT LABORATORIES, INC.
K842470 MILES LABORATORIES, INC.
K042939 Sebia, Inc. 13805 WATERLOO
CHELSEA MI 48118
K083602 SENTINEL CH. SpA Via Robert Koch, 2
Milano 20152
K082503 SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC
NEWARK DE 19714-6101
K182098 Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76
Marburg 35041
K171742 Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76
Marburg 35041
K190879 Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Str-76
Marburg 35041
K120056 THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD
BIRMINGHAM, WEST MIDLANDS B15 1QT
K150658 THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD,
BIRMINGHAM B15 1QT
K173732 The Binding Site Group Ltd 8 Calthorpe Road Edgbaston
Birmingham B15 1QT
K023009 THE BINDING SITE, LTD. EAST TOWER, SUITE 600
SANTA MONICA CA 90404
K070900 THE BINDING SITE, LTD. EAST TOWER, SUITE 600
SANTA MONICA CA 90404
K062372 THE BINDING SITE, LTD. WEST TOWER, SUITE 4000
SANTA MONICA CA 90404
K051915 THE BINDING SITE, LTD. WEST TOWER, SUITE 4000
SANTA MONICA CA 90404
K040009 THE BINDING SITE, LTD. WEST TOWER, SUITE 4000
SANTA MONICA CA 90404
K003669 THE BINDING SITE, LTD. WEST TOWER, SUITE 4000
SANTA MONICA CA 90404
K002564 THE BINDING SITE, LTD. WEST TOWER, SUITE 4000
SANTA MONICA CA 90404




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