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510(k) K843654

CHLAMYDIA by Institute Virion , Ltd. — Product Code GPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1985
Date Received
September 17, 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 Institute Virion , Ltd.

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

Other clearances for product code GPW

  • K872700 — YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN (October 15, 1987)
  • K844868 — CHLAMYDIA GROUP CF ANTIGEN (March 5, 1985)
  • K811570 — ANTIBODY TO CHLAMYDIA TRACHOMATIS (July 23, 1981)