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510(k) K864597

GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA by Gen-Probe, Inc. — Product Code LQF

K864597 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA". The FDA issued a decision of Substantially Equivalent on April 20, 1987. The device falls under product code LQF (Dna-Reagents, Mycobacterium Spp.), a Class I device regulated under 21 CFR 866.3370. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1987
Date Received
November 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Mycobacterium Spp.
Device Class
Class I
Regulation Number
866.3370
Review Panel
MI
Submission Type

Other clearances by Gen-Probe, Inc.

  • K122062 — APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER (January 9, 2013)
  • K111409 — APTIMA COMBO 2 ASSAY (May 3, 2012)
  • K063664 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (January 25, 2007)
  • K063451 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (January 22, 2007)
  • K062440 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (November 7, 2006)
  • K061413 — APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (October 13, 2006)
  • K061509 — TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (October 4, 2006)
  • K060652 — TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (August 17, 2006)
  • K053446 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (July 25, 2006)
  • K043224 — GEN-PROBE APTIMA COMBO 2 ASSAY (August 9, 2005)

Other clearances for product code LQF

  • K921435 — ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (July 23, 1992)
  • K904463 — ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST (November 13, 1990)
  • K896494 — ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST (August 23, 1990)
  • K897077 — ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE (August 23, 1990)
  • K897078 — ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (May 2, 1990)
  • K896492 — ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST (April 16, 1990)
  • K896493 — ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST (April 11, 1990)
  • K900202 — SNAP MYCOBACTERIA AVIUM COMPLEX (April 3, 1990)
  • K900292 — SNAP M. TUBERCULOSIS COMPLEX (April 3, 1990)
  • K890089 — RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (March 13, 1989)

FDA data resources