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510(k) K874606

CATHRA GRAM POSITIVE SCREEN by Mct Medical, Inc. — Product Code LQL

K874606 is an FDA 510(k) premarket notification submitted by Mct Medical, Inc. for the device "CATHRA GRAM POSITIVE SCREEN". The FDA issued a decision of Substantially Equivalent on May 6, 1988. The device falls under product code LQL (Gram Positive Identification Panel), a Class I device regulated under 21 CFR 866.2660. Mct Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1988
Date Received
November 9, 1987
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 Mct Medical, Inc.

  • K880504 — MCT MEDICAL BROWNE UROSCAN URODYNAMIC (June 17, 1988)
  • K861958 — REPLIANALYZER (August 1, 1986)

Other clearances for product code LQL

  • K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (January 22, 1998)
  • K961730 — RAPID GRAM-POSITIVE ID SYSTEM (February 4, 1997)
  • K961968 — BBLCRYSTAL 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)
  • K910537 — VISI-STREP (April 12, 1991)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K891004 — RAPIDEC STAPH (November 9, 1989)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)

FDA data resources