Home / 510(k) Clearances / K870117

510(k) K870117

NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST by Pro-Lab, Inc. — Product Code JSX

K870117 is an FDA 510(k) premarket notification submitted by Pro-Lab, Inc. for the device "NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST". The FDA issued a decision of Substantially Equivalent on March 20, 1987. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Pro-Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1987
Date Received
January 12, 1987
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 Pro-Lab, Inc.

  • K934383 — PROLEX (STREPTOCCAL GROUPING LATEX KIT) (January 27, 1995)
  • K914419 — AMNIOTEST(TM) (September 1, 1993)
  • K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (July 28, 1992)
  • K903714 — E. COLI 0157 LATEX TEST (January 24, 1991)
  • K894221 — ROSCO PYRR (September 28, 1989)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K871121 — PROTECT T.M. (April 14, 1987)
  • K861142 — MASTER KIT B (July 10, 1986)
  • K861889 — D'ALA RAPID TEST (June 3, 1986)

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)
  • K853544 — QUAD FERM + (September 5, 1985)
  • K852998 — NEISSERIA - KWIK PLUS (July 23, 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