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510(k) K910302

ECLIPSE ICA ANALYZER by Biotope, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1991
Date Received
January 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

Other clearances by Biotope, Inc.

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  • K910256 — ECLIPSE ICA TSH (February 22, 1991)
  • K905601 — ECLIPSE ICA TRIGLYCERIDES (January 17, 1991)
  • K905719 — ECLIPSE ICA DIGOXIN (January 17, 1991)
  • K905602 — ECLIPSE ICA BUN (January 16, 1991)
  • K905144 — ECLIPSE ICA GLUCOSE (January 4, 1991)

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  • K961183 — CBI 7520 READER (August 2, 1996)
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  • K955077 — ANTHOS 2010 READER (December 4, 1995)
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  • K953572 — ELX800UV (October 19, 1995)