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510(k) K852998

NEISSERIA - KWIK PLUS by Micro-Bio-Logics — Product Code JSX

K852998 is an FDA 510(k) premarket notification submitted by Micro-Bio-Logics for the device "NEISSERIA - KWIK PLUS". The FDA issued a decision of Substantially Equivalent on July 23, 1985. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Micro-Bio-Logics has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1985
Date Received
July 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Neisseria Gonorrhoeae
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Micro-Bio-Logics

  • K870731 — LYFO KWIK(TM) RUS KIT (June 17, 1987)
  • K861312 — LYFO-KWIK (TM) COAGULASE PLASMA (April 18, 1986)
  • K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (April 4, 1986)
  • K855172 — KWI (TM) G-CO/TWO (February 20, 1986)
  • K855198 — INDI KWIK (TM) CO/TWO KIT (January 14, 1986)
  • K851978 — LYFO-KWIK OMI KIT (June 4, 1985)
  • K844014 — ONO/CO-TWO (TM) SYSTEMS (October 31, 1984)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)

Other clearances for product code JSX

  • K960759 — GONOPOX TEST KIT (September 18, 1996)
  • K923566 — NIZYME TEST KIT (November 2, 1992)
  • K913456 — VISI-NEISSERIA (October 11, 1991)
  • K880511 — XACT NEISSERIA (August 25, 1988)
  • K881501 — MODIFIED IDS RAPID NH SYSTEM (May 18, 1988)
  • K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (March 20, 1987)
  • K853544 — QUAD FERM + (September 5, 1985)
  • K852582 — GONI-KIT (July 12, 1985)
  • K833307 — PHADEBACK G.C. POSITIVE CONTROLS (December 27, 1983)
  • K833180 — GONOCHEK-II (November 14, 1983)

FDA data resources