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510(k) K891004

RAPIDEC STAPH by Dms Products, Inc. — Product Code LQL

K891004 is an FDA 510(k) premarket notification submitted by Dms Products, Inc. for the device "RAPIDEC STAPH". The FDA issued a decision of Substantially Equivalent on November 9, 1989. The device falls under product code LQL (Gram Positive Identification Panel), a Class I device regulated under 21 CFR 866.2660. Dms Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1989
Date Received
February 28, 1989
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 Dms Products, Inc.

  • K894805 — RAPIDEC UR (September 26, 1989)
  • K890626 — RAPIDEC COLI (June 2, 1989)
  • K890625 — JAMES REAGENT (February 17, 1989)
  • K854733 — API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) (March 6, 1986)
  • K854732 — API 50 CHB (CULTURE MEDIA) (March 4, 1986)

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)
  • K910537 — VISI-STREP (April 12, 1991)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K874606 — CATHRA GRAM POSITIVE SCREEN (May 6, 1988)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)

FDA data resources