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510(k) K812121

DIGICLOT 2-#820 by Volu Sol Medical Industries — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
July 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Volu Sol Medical Industries

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  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821533 — HEMATOXYLIN I (June 10, 1982)

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