Home / 510(k) Clearances / K850003

510(k) K850003

COXSACKIE B SERIES CF ANTIGENS by Hillcrest Biologicals — Product Code GNG

K850003 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "COXSACKIE B SERIES CF ANTIGENS". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code GNG (Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6), a Class I device regulated under 21 CFR 866.3145. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
January 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
Device Class
Class I
Regulation Number
866.3145
Review Panel
MI
Submission Type

Other clearances by Hillcrest Biologicals

  • K913618 — ARBOVIRUS IGM IFA TEST (December 3, 1992)
  • K913617 — ARBOVIRUS IGG IFA TEST (December 3, 1992)
  • K922374 — Q FEVER IGM IFA TEST (October 21, 1992)
  • K913906 — Q FEVER IGG IFA TEST (October 21, 1992)
  • K900206 — LYME DISEASE IGM ELISA (June 28, 1991)
  • K896594 — EBV VCA ANTIBODY (IGM) (January 16, 1990)
  • K884829 — EBV EARLY ANTIGEN (R+D) (April 12, 1989)
  • K883767 — LYME DISEASE IFA (IGM) (March 15, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K883487 — LYME DISEASE IFA (IGG) (December 13, 1988)

Other clearances for product code GNG

  • K921618 — COXSACKIE VIRUS B1-B6 CF ANTIGENS (June 29, 1992)

FDA data resources