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510(k) K791897

BACTO-HATTS by Difco Laboratories, Inc. — Product Code GMT

K791897 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "BACTO-HATTS". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code GMT (Antigens, Ha, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
September 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
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)
  • K954784 — DRYSIDE NEISSERIA (January 30, 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)

Other clearances for product code GMT

  • K971502 — SERODIA TP-PA (November 13, 1997)
  • K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (July 24, 1991)
  • K911266 — MODIFIED PK TP CONTROL (May 7, 1991)
  • K905038 — OLYMPUS PK-TP ABSORBENT KIT (May 6, 1991)
  • K896410 — CELLOGNOST SYPHILIS H (May 15, 1990)
  • K893124 — OLYMPUS PK(TM) TP (November 17, 1989)
  • K791457 — AGGLUTINOTEST-SYPHILIS (September 24, 1979)
  • K760098 — REAGENT, VDRL (August 3, 1976)

FDA data resources