Home / 510(k) Clearances / K900202

510(k) K900202

SNAP MYCOBACTERIA AVIUM COMPLEX by Syngene, Inc. — Product Code LQF

K900202 is an FDA 510(k) premarket notification submitted by Syngene, Inc. for the device "SNAP MYCOBACTERIA AVIUM COMPLEX". The FDA issued a decision of Substantially Equivalent on April 3, 1990. The device falls under product code LQF (Dna-Reagents, Mycobacterium Spp.), a Class I device regulated under 21 CFR 866.3370. Syngene, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1990
Date Received
January 16, 1990
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 Syngene, Inc.

  • K900292 — SNAP M. TUBERCULOSIS COMPLEX (April 3, 1990)

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)
  • K900292 — SNAP M. TUBERCULOSIS COMPLEX (April 3, 1990)
  • K890089 — RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (March 13, 1989)
  • K871795 — RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. (July 30, 1987)

FDA data resources