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510(k) K844567

TITERTEK TWINREADER 78-630-00 by Flow Laboratories, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
November 23, 1984
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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  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
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  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)

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