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510(k) K834338

MYCOPLASMA PNEUMONIAE CF ANTIGEN by Hillcrest Biologicals — Product Code GSB

K834338 is an FDA 510(k) premarket notification submitted by Hillcrest Biologicals for the device "MYCOPLASMA PNEUMONIAE CF ANTIGEN". The FDA issued a decision of Substantially Equivalent on February 27, 1984. The device falls under product code GSB (Antigens, Cf, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Hillcrest Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
December 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf, All, Mycoplasma Spp.
Device Class
Class I
Regulation Number
866.3375
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 GSB

  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)
  • K843664 — MYCOPLASMA PNEUMONIAE (October 25, 1984)
  • K832132 — SERA-TEK MYCOPLASMA ANTIBODY TEST (September 20, 1983)
  • K802934 — MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (December 31, 1980)

FDA data resources