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510(k) K852986

GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN by Clinical Technology Corp. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
July 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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  • K854231 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES (May 2, 1986)
  • K853507 — STERI-GRIP (September 5, 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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