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510(k) K760162

HEMATOLOGY CONTROL by Biological Corp. of America — Product Code JPK

K760162 is an FDA 510(k) premarket notification submitted by Biological Corp. of America for the device "HEMATOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Biological Corp. of America has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 6, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Biological Corp. of America

  • K813404 — FREEZE DRIED FICIN (February 10, 1982)
  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K812222 — EM-X (September 23, 1981)
  • K810803 — FREEZE DRIED PAPAIN (July 21, 1981)
  • K781397 — EM-V (September 14, 1978)

Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources