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510(k) K872867

BIOSIGN by Clinical Technology Corp. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1988
Date Received
July 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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  • K853507 — STERI-GRIP (September 5, 1985)
  • K852986 — GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN (August 19, 1985)
  • K844565 — BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) (February 21, 1985)
  • K841272 — SICKLE-STAT HEMOGLOBIN S SCREEN KIT (April 13, 1984)
  • K823077 — URINARY BLADDER TEMP. SENSOR #81-003 (March 9, 1983)

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