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510(k) K844868

CHLAMYDIA GROUP CF ANTIGEN by Hillcrest Biologicals — Product Code GPW

K844868 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "CHLAMYDIA GROUP CF ANTIGEN". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code GPW (Antigen, Cf, Psittacosis (Chlamydia Group)), a Class I device regulated under 21 CFR 866.3120. 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
December 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf, Psittacosis (Chlamydia Group)
Device Class
Class I
Regulation Number
866.3120
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 GPW

  • K872700 — YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN (October 15, 1987)
  • K843654 — CHLAMYDIA (August 8, 1985)
  • K811570 — ANTIBODY TO CHLAMYDIA TRACHOMATIS (July 23, 1981)

FDA data resources