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510(k) K910304

RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA by Vitek Systems, Inc. — Product Code LQL

K910304 is an FDA 510(k) premarket notification submitted by Vitek Systems, Inc. for the device "RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code LQL (Gram Positive Identification Panel), a Class I device regulated under 21 CFR 866.2660. Vitek Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
January 24, 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 Vitek Systems, Inc.

  • K920661 — VIDAS CMV IGG ASSAY (February 12, 1993)
  • K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (July 28, 1992)
  • K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (April 8, 1992)
  • K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY (April 7, 1992)
  • K915884 — VIDAS CHLAMYDIA ASSAY, MODIFICATION (March 4, 1992)
  • K905211 — VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY (October 11, 1991)
  • K912371 — BIOMERIEUX RSV DIRECT IF KIT (September 23, 1991)
  • K910230 — LYME-SPOT IF KIT (August 30, 1991)
  • K910210 — SLIDEX MENINGITE-KIT 5 (August 12, 1991)
  • K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (June 24, 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)
  • K910537 — VISI-STREP (April 12, 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