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510(k) K880290

MICROTRAK CMV CULTURE CONFIRMATION TEST by Syva Co. — Product Code GQH

K880290 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "MICROTRAK CMV CULTURE CONFIRMATION TEST". The FDA issued a decision of Substantially Equivalent on April 19, 1988. The device falls under product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1988
Date Received
January 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

Other clearances by Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)

Other clearances for product code GQH

  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (May 5, 1994)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)
  • K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG (August 3, 1988)
  • K881932 — ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (August 1, 1988)
  • K880679 — BION CMV-G TEST SYSTEM (June 3, 1988)
  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)
  • K873114 — CYTOMEGALOVIRUS CONTROL SLIDES (September 25, 1987)
  • K864565 — MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT (February 19, 1987)

FDA data resources