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510(k) K954784

DRYSIDE NEISSERIA by Difco Laboratories, Inc. — Product Code LTS

K954784 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "DRYSIDE NEISSERIA". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code LTS (Test Reagents, Neisseria Gonorrhoeae Biochemical), a Class I device regulated under 21 CFR 866.2660. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
October 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test Reagents, Neisseria Gonorrhoeae Biochemical
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Difco Laboratories, Inc.

  • K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN (April 14, 1997)
  • K971211 — DISPENS-O-DISC SPARFLOXACIN (April 14, 1997)
  • K963508 — DISPENS-O-DISC MEROPENEM (September 26, 1996)
  • K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) (April 26, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)
  • K953129 — ESP CULTURE SYSTEM - MYCO (December 26, 1995)
  • K950706 — DRYSLIDE COAGULASE (May 16, 1995)
  • K944275 — DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. (December 19, 1994)
  • K941016 — DISPENS-O-DISC(TM) NITROCEFIN (June 30, 1994)
  • K934894 — CULTURESWAB TRANSPORT SYSTEM (February 22, 1994)

FDA data resources