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510(k) K843664

MYCOPLASMA PNEUMONIAE by Institute Virion , Ltd. — Product Code GSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1984
Date Received
September 17, 1984
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 Institute Virion , Ltd.

  • K862814 — COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (September 30, 1986)
  • K843657 — CYTOMEGALOVIRUS (September 26, 1985)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K843662 — MEASLES VIRUS RUBEOLA (September 26, 1985)
  • K843659 — INFLUENZA A2 VIRUS (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843660 — IN FLUENZA B VIRUS (September 26, 1985)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K843673 — RESPIRATORY SYNCYTIAL VIRUS (September 26, 1985)

Other clearances for product code GSB

  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)
  • K834338 — MYCOPLASMA PNEUMONIAE CF ANTIGEN (February 27, 1984)
  • K832132 — SERA-TEK MYCOPLASMA ANTIBODY TEST (September 20, 1983)
  • K802934 — MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (December 31, 1980)