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510(k) K853165

ECHO TYPE 30 CF ANTIGEN by Hillcrest Biologicals — Product Code GNK

K853165 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "ECHO TYPE 30 CF ANTIGEN". The FDA issued a decision of Substantially Equivalent on November 7, 1985. The device falls under product code GNK (Antisera, Cf, Echovirus 1-34), a Class I device regulated under 21 CFR 866.3205. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1985
Date Received
July 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Echovirus 1-34
Device Class
Class I
Regulation Number
866.3205
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)
  • K913906 — Q FEVER IGG IFA TEST (October 21, 1992)
  • K922374 — Q FEVER IGM 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 GNK

  • K853157 — ECHO TYPE 11 CF ANTIGEN (November 7, 1985)
  • K853156 — ECHO TYPE 16 CF ANTIGEN (November 7, 1985)

FDA data resources