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510(k) K852930

VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO by Microbix Biosystems, Inc. — Product Code GQX

K852930 is an FDA 510(k) premarket notification submitted by Microbix Biosystems, Inc. for the device "VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code GQX (Antiserum, Cf, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Microbix Biosystems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
July 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
Review Panel
MI
Submission Type

Other clearances by Microbix Biosystems, Inc.

  • K894261 — TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • K852931 — HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)
  • K852932 — MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)
  • K852929 — CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (November 12, 1985)
  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)

Other clearances for product code GQX

  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • K911301 — VZV IGM TEST (July 17, 1991)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K875358 — VZV TEST (March 31, 1988)
  • K863317 — ENZYGNOST ANTI-VZV IGG TEST (April 22, 1987)
  • K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (February 4, 1986)
  • K842096 — GLB VARICELLA-ZOSTER VIRUS FLUORESCENT (January 7, 1985)
  • K841526 — ORTHO VARICELLA-ZOSTER VIRUS IDENT. (June 25, 1984)
  • K770810 — VARICELLA-ZOSTER FA LABELED PRESERUM (May 20, 1977)
  • K770806 — VARICELLA-ZOSTER FA LABELLED (8-321 RF) (May 20, 1977)

FDA data resources