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510(k) K910537

VISI-STREP by Kev Connecticut Diagnostics, Inc. — Product Code LQL

K910537 is an FDA 510(k) premarket notification submitted by Kev Connecticut Diagnostics, Inc. for the device "VISI-STREP". The FDA issued a decision of Substantially Equivalent on April 12, 1991. The device falls under product code LQL (Gram Positive Identification Panel), a Class I device regulated under 21 CFR 866.2660. Kev Connecticut Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
February 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram Positive Identification Panel
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Kev Connecticut Diagnostics, Inc.

  • K913456 — VISI-NEISSERIA (October 11, 1991)

Other clearances for product code LQL

  • K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (January 22, 1998)
  • K961968 — BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (February 4, 1997)
  • K961730 — RAPID GRAM-POSITIVE ID SYSTEM (February 4, 1997)
  • K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (March 12, 1996)
  • K925916 — VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD (March 23, 1993)
  • K910304 — RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (July 26, 1991)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K891004 — RAPIDEC STAPH (November 9, 1989)
  • K874606 — CATHRA GRAM POSITIVE SCREEN (May 6, 1988)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)

FDA data resources