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510(k) K861897

UNISKAN II by Flow Laboratories, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1986
Date Received
May 16, 1986
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

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  • K860752 — GOAT SERUM (29-391-54) (March 10, 1986)
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  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)
  • K844567 — TITERTEK TWINREADER 78-630-00 (March 21, 1985)

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