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510(k) K880076

G-MARK by Bainbridge Laboratories, Inc. — Product Code LIC

K880076 is an FDA 510(k) premarket notification submitted by Bainbridge Laboratories, Inc. for the device "G-MARK". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code LIC (Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. Bainbridge Laboratories, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1988
Date Received
January 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

Other clearances by Bainbridge Laboratories, Inc.

  • K912215 — PYLORITRAK (October 4, 1991)

Other clearances for product code LIC

  • K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATION (May 22, 1992)
  • K911430 — IDEIA(TM) CHLAMYDIA, MODIFICATION (August 7, 1991)
  • K874078 — MERITEC(TM)-GC (December 9, 1987)
  • K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (May 13, 1987)
  • K851650 — PHADEBACT MONOCLONAL GC OMNI TEST (July 12, 1985)
  • K850351 — PHADEBACT MONOCLONAL GC TEST (March 13, 1985)
  • K821362 — IMPROVED GONO GEN (August 4, 1982)
  • K820007 — NEISSERIA GONORRHOEAE TEST (January 29, 1982)

FDA data resources