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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K883749
Device Name PROBE(TM) MODELS 700 AND 1000
Applicant
PACKARD INSTRUMENT CO., INC.
2200 WARRENVILLE RD.
DOWNERS GROVE,  IL  60515
Applicant Contact GEORGE L RUSSELL
Correspondent
PACKARD INSTRUMENT CO., INC.
2200 WARRENVILLE RD.
DOWNERS GROVE,  IL  60515
Correspondent Contact GEORGE L RUSSELL
Regulation Number862.2750
Classification Product Code
JQW  
Date Received09/01/1988
Decision Date 11/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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